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SAL Hospital and Medical Institute
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Research Projects undertaken by Care Cardiovascular Consultants as an Investigator

Sr. No.
Investigational Product
Indication
Study Phase
Status
PHARMACOLOGICAL AGENT
1

Allogenic Stem cell

Post MI

I

Ongoing

2

Oral Anti platelet drug

Acute Coronary Syndrome

II

Ongoing

3

Oral Anti Thrombotic drug

Acute Coronary Syndrome

II

Completed with Highest enrollment in India

4

Oral Anti Coagulant drug

Acute Coronary Syndrome

II

Completed with Highest enrollment in India

5

ACE Inhibitor in Children

Paediatric Hypertension

II

Completed

6

Anti hyperlipidemic drug

Dyslipidemia

II

Completed

7

Endothelin Antagonist

Pulmonary Hypertension

III

Ongoing

8

Anti hyperlipidemic drug

Chronic Coronary Artery Heart Disease

III

Ongoing with Highest enrollment in India

9

Oral Anti platelet drug

Acute Coronary Syndrome

III

Ongoing with Highest enrollment in India

10

Oral Anti platelet drug (R)

Non-Valvular Atrial Fibrillation

III

Ongoing

11

Oral Anti platelet drug (A)

Non-Valvular Atrial Fibrillation

III

Ongoing

12

Oral Anti Coagulant drug

Secondary prevention of venous thromboembolism

III

Ongoing

13

SC Anti Coagulant drug

Atrial Fibrillation

III

Ongoing

14

Prostacyclin analogue

Pulmonary Arterial Hypertension

III

Ongoing

15

Anti Anginal drug

Stable angina pectoris

III

Ongoing

16

Haematopoetic agent

Heart Failure with anemia

III

Ongoing

17

Oral Anti platelet drug (R)

Medically ill patients at risk of DVT

III

Ongoing

18

IV Anti platelet drug

Percutaneous Coronary Intervention (PCI)

III

Enrolment completed.

19

Oral Anti platelet drug

STEMI / NSTEMI

III

Enrolment completed.

20

IV GPIIb/ IIIa drug

NSTEMI

III b

Enrolment completed. 4th highest enrolment in world

21

IV Abciximab

Percutaneous Coronary Intervention (PCI)

III

Completed

22

Oral Anti Coagulant drug

Non-Valvular Atrial Fibrillation

III

Completed

23

Angiotenion Receptor Blocker

Paediatric Hypertension

III

Completed

24

Prostacyclin Infusion

Pulmonary Arterial Hypertension

III

Completed

25

OASIS 5 (LMWH)

Acute Coronary Syndrome

III

Study completed, 100% Follow up. One of the highest enrollments in the country.

26

OASIS 6 (LMWH)

Acute Myocardial Infarction

III

Enrollment completed.100% Follow up of enrolled patients.

27

EXTRACT TIMI-25 (LMWH)

Acute Coronary Syndrome

III

Study completed, 100% Follow up

28

SC Anti Coagulant drug

Percutaneous Coronary Intervention (PCI)

IV

Ongoing

29

Aliskiren (RESILAZ)

Essential Hypertension

IV

Ongoing

30

POLYCAP

Patient at atleast one CV risk

IV

Completed

31

Oral Antiplatelet drug

Acute Coronary Syndrome

IV

Completed

32

IV Anti Coagulant drug

Percutaneous Coronary Intervention (PCI)

IV

Completed

33

Newer Generation Statin

Hyperlipidemia

III

Completed

34

Tirofiban GPIIb/ IIIa Inhibitor

Percutaneous Coronary Intervention (PCI)

IV

Completed

35

Newer Generation Statin - Pitavastatin

Hyperlipidemia

IV

Completed

SURGERY
36
Comparison of CABG and optimum medical therapy
Coronary Artery Disease
IV
Follow up Ongoing
INVESTIGATIONAL/ MARKETED DEVICE
37

Neovasc: Coronary Sinus Stent

Coronary Artery Disease.

FIM

Completed

38

Papirus:Implantable Ultrasonic device

Heart Failure

FIM

Completed

39

Rotational Atherectomy Device

Stable Angina

FIM

Completed

40

Thrombosuction Catheter

Primary Angioplasty in MI

Pre Marketing

Completed

41

Zotarolimus-Eluting Coronary Stent

Percutaneous Coronary Intervention (PCI)

IV

Enrolment completed, with Highest in India

42

CYPHER Select Sirolimus-eluting Coronary Stent

Percutaneous Coronary Intervention (PCI)

IV

Enrolment completed

43

Randomized DES study

Percutaneous Coronary Intervention (PCI)

IV

Enrolment completed, with Highest in India

44

Paclitaxel-Eluting Coronary Stent

Percutaneous Coronary Intervention (PCI)

IV

Completed

45

E CYPHER Registry

Percutaneous Coronary Intervention (PCI)

IV

Study completed, with highest enrolment

46

Implantable Cardiac Device

Arrythmias

IV

Ongoing

47

Digital pacemaker Registry

Arrythmias

IV

Completed

48

ABT-578 Drug Eluting coronary Stent

Percutaneous Coronary Intervention (PCI)

IV

Study completed, with highest enrolment

49

Percu Serge™ Gaurdwire (RUBY)

Percutaneous Coronary Intervention (PCI)

IV

Completed

 

PROJECTS UNDERTAKEN BY CCC FOR INDEPENDENT INVESTIGATORS
1

Effect of Folate treatment on Homocystenemia in cardiac patients: A prospective study.

2

Reversal of Slow or no reflow during Percutaneous Transluminal Coronary Angioplasty during intracoronary boluses of Adenosine and Sodium Nitroprusside in combination.

3

Pharmacoepidemiology and Risk factors of Hypertension in western Gujarat.

4

Effect of statins and their combination with fenofibrate in patients undergoing percutaneous transluminal coronary angioplasty.

5

Effect of Niacin treatment on hyperlipoproteinemia in coronary artery disease patients.

6

Effect of combinations of various intracoronary drugs in no-reflow patients undergoing percutaneous coronary intervention.

7

Comparison of drug eluting stent with conventional S7 Stent.

8

The use of distal protection device (DPD) during angioplasty and to compare the acute long-term events of intracoronary injections of drugs in no-reflow as compared to distal protection device.

9

Assessment of risk factors for coronary artery disease.

10

High prevalence of renal artery stenosis in hypertensive patients with triple vessel coronary artery disease: recommendation for simultaneous renal

11

Arteriogram for earlier intervention.

12

Effect of pioglitazone and its combination with statins in CAD patients with hyperinsulinemia.

13

Safety and Efficacy of High Dose Intracoronary bolus of tirofiban in patients with AMI undergoing Primary / Rescue coronary angioplasty.

14

Short term and Long term effect of Metoprolol XL on PAP in patients with CHF using first in human implantable device responding to ultrasonic signal.

15

Comparison of Short Term and Long term Effect of Metoprolol XL versus Carvedilol on Pulmonary artery Pressure in patients with chronic Heart Failure using first in human implantable device responding to ultrasonic signal.

16

First in human CT angiography images of "Pulmonary artery Stenting with a transducer device" in patients with heart failure.

17

Effects of Cardiac Rehabilitiation on PA pressure in patients with Chronic Heart Failure using first in human implantable device responding to ultrasonic signal.

18

How to treat Heart Failure? Is there any difference after ambulatory PA pressure monitoring.

19

Diurnal variation in PA pressure measured using First in Human implantable device responding to ultrasonic signals.

20

Association of BNP and PA pressure monitored through first in human implantable device in patients with HF.

21

Acute effects on Pulmonary artery pressure, on rest and after exercise in patients in patients with heart failure (EF<35%) using first in human implantable device for PAP responsing to ultrasonic signals.

22

Comparison of Chronical HF device (Medtronic) versus Remon CHF system (Remon) for ambulatory PAP measurement in patients with heart failure.

23

First in human pilot study of safety and efficacy of Neovasc Reducer Implant in the treatment of ischemic heart disease by controlled narrowing of the coronary sinus, in patients with No-Options.

24

Evaluation of Coronary arterial system and collaterals subsequent to first in human Neovasc Reducer TM Implantation in Coronary Sinus in “No Options” patients using 40 Slice Multi-detector Computed Tomography .

25

Non invasive Visualization of first in human Neovasc Reducer TM Implant in Coronary Sinus using 40 Slice Multi-detector Computed Tomography.

26
Effect of Coronary Sinus Retroperfusion Stent (Neovasc Reducer®) on angiogenic, inflammatory and genetic markers.

 

RESEARCH PAPERS
1

Ovalum CiTopTM: A Novel Guidewire for crossing Chronic Total Occlusion in Coronary Artery Disease patients – First-in-Man Experience. Euro Intervention Supplement E Volume 5 May 2009.

2

Effect of Metoprolol CR/XL on Pulmonary Artery Pressure in Chronic Heart Failure Patients Assessed by an Implanted Ultrasonic Device with Special Emphasis on Diurnal Variation and Exercise Capacity; Indian Heart Journal Volume 61 No. 1, January-February 2009.

3

Intracoronary boluses of adenosine and sodium nitroprusside in combination reverse slow/no-reflow during angioplasty: a clinical scenario of ischemic preconditioning. Can J Physiol Pharmacol. 2007 Mar-Apr; 85(3-4):476-82.

4

Coronary Sinus Reducer-Stent for the Treatment of Chronic Refractory Angina Pectoris: A prospective, open label, multi-center safety feasibility first-in-man study. J Am. Coll. Cardiol 2007; 49:1783-1789.

5

Wireless acoustic communication with a miniature pressure sensor in the pulmonary artery for disease surveillance and therapy of patients with congestive heart failure. J Am Coll Cardiol 2007; 49:784-9.

6

First–In-Man Study: Effect of Metoprolol CR/XL Uptitration on pulmonary artery pressure and its variation in chronic heart failure monitored non-invasively using an implanted device responding to ultrasonic signals. Indian Heart J 2009

7

Efficacy of Percusurge in Acute Myocardial Infarction patients undergoing Revascularization with a special emphasis on Procedural time. Ind Heart J 2008.

8
Beneficial Effects of Addition of Fenofibrate to Statin Therapy in Patients with Acute Coronary Syndrome after Percutaneous Coronary Interventions. Exp Clin Cardiol 2007, 12:91-6.

 

REVIEW ARTICLES
1

Investigational Treatments and Future Directions in Heart Failure. Cardiol Today 2007; 12:96-103.

2

Basics of Stem Cell Therapy in Heart Failure. Cardiol Today 2007; 12: 104-114

3

Homocysteine and Coronary Artery Disease. Ind J Pharm Sci 2004; 66: 595-601

4

Molecule of the Millennium: Bosentan in Primary Pulmonary Hypertension. Ind J Pharmacol 2004; 36: 118

5

Prevalence of Hyperhomocysteinemia in Western Indian Population with or without Coronary Artery Disease.        Ind J Cardiol 2003; 6: 54-58

6

HPCR Guidelines for Heart Failure Therapeutics. Ind Heart J 2000; 52: 6

7

Ischemic Heart Disease Endothelial Dysfunction. Ind Heart J 2000; 52: 6

8

Gujarat Earthquake – A Cardiologist’s Perspective. Ind Heart J 2002

9
Use of Abciximab (Reopro): In High Risk Coronary Artery Disease Patients during angioplasty and Stents. Guj Med J 1999; 56: 1

 

ABSTRACTS AND PRESENTATIONS IN INTERNATIONAL AND NATIONAL CONFERENCES
1

Long Term Safety, Angina Relief and Improvement in Quality of Life in Patients with Refractory Angina Treated with the Neovasc Coronary Sinus Reducer. Presented at ACC 2009

2

First In Man Assessment Of Orbital Atherectomy System In Treating De Novo Calcified Coronary Lesion (ORBIT I). Presented at ACC 2009

3

Randomized, Multi-centric, Open label study to evaluate safety & efficacy of Faximab, A biosimailar Abciximab in Indian patients undergoing percutaneous coronary intervention; Submitted to Indian Heart Journal in August 2008.

4

Safety & efficacy of indigenously developed and manufactured Bivalirudin in moderate/high risk indian patients undergoing percutaneous coronary intervention; Bivaflow registry; Indian Heart J: July-Aug, Volume 60, No.4.

5

First-in-man: Effect of Metoprolol CR/XL uptitration on pulmonary artery pressure and its variation in chronic heart failure monitored non-invasively by an implanted device using ultrasonic signals. Presented at European Society of Cardiology Congress, September 2007.

6

Association Between the White Blood Cell Count and Occurrence of Slow or No Reflow Phenomenon in Patients with Acute Coronary Syndromes in the Coronary Interventional Era. Presented at Annual Conference of The Cardiological Society of India (CSI-2006) Ind Heart J 2006; 58:436

7

Incidences and Clinical Characteristics of No Reflow after Percutaneous Coronary Interventions in High Risk Asian Indian Patients. Presented at Annual Conference of The Cardiological Society of India (CSI-2006) Ind Heart J 2006; 58:418

8

Initial Clinical Experience with Bivalirudin as an Anticoagulant during Percutaneous Coronary Interventions in Asian Indian patients. Presented at Annual Conference of The Cardiological Society of India (CSI-2006) Ind Heart J 2006; 58:435-6

9

Prospective randomized study of Percusurge in acute myocardial infarction patients undergoing revascularization with a special emphasis on procedural time: A two year follow-up. Presented at Annual Conference of The Cardiological Society of India (CSI-2006) Ind Heart J 2006; 58:417-8

10

High prevalence of renal artery stenosis in hypertensive patients with triple vessel coronary artery disease: recommendation for simultaneous renal arteriogram for earlier intervention. Presented at Annual Conference of The Cardiological Society of India (CSI-2006) Ind Heart J 2006; 58:454

11

First-In-Man: Direct Comparison of Conventional Coronary Sinus Angiography and CT Angiography for Visualization and Sizing of Coronary Sinus. Presented at International Symposium of Transcatheter Cardiovascular Therapeutics (TCT) 2006, Washington DC

12

First-In-Man: Multi-Slice CT Angiography        Visualization of an Innovative First-in-Man Coronary Sinus Reducer Stent in Patients with Refractory Angina. Presented at International Symposium of Transcatheter Cardiovascular Therapeutics (TCT) 2006, Washington DC

13

First-In-Man: Measurement of diurnal variation in Pulmonary Artery Systolic and Diastolic Pressure in Heart Failure Patients Using an Innovative Implantable Device Responding to Ultrasonic Signals. Eur Heart J 2006; 27 (Abstract Supplement): 485

14

First–In-Man: Non-Invasive Measurement of Variation in Pulmonary Artery Pressure Following Exercise in Heart Failure Patients Using an Innovative Implantable Device Involving Acoustic Telemetry. Eur Heart J 2006; 27 (Abstract Supplement): 949

15

First-In-Man: Effect of Metoprolol CR/XL on Exercise Capacity and Subsequent Variation in Pulmonary Artery Pressure in Heart Failure Patients Using an Innovative Implant Involving Acoustic Telemetry.  Eur Heart J 2006; 27 (Abstract Supplement): 949

16

First-In-Man Non-Invasive Monitoring of Pulmonary Artery Pressure from an Implantable Device Using Acoustic Telemetry: A One Year Follow-Up Data. Eur Heart J 2006; 27 (Abstract Supplement): 202

17

First-In-Man: Comparison of Impressure Device Measuring Pulmonary Artery Pressure Non-invasively with Conventional Contrast Echocardiography in Congestive Heart Failure. Eur Heart J 2006; 27 (Abstract Supplement): 202

18

First-In-Man study: Effect of Metoprolol CR/XL on Diurnal Variation in Pulmonary Artery Pressure Assessed Non-invasively Using an Innovative Implantable Device Responding to Ultrasonic Signals. Eur Heart J 2006; 27 (Abstract Supplement): 344

19

Intracoronary Boluses of Adenosine and Sodium Nitroprusside Combination Reverses Slow/No Reflow During Angioplasty: A Clinical Scenario of Experimental Preconditioning. Oral and Poster presentation at the Young Investigator’s Awards Competition, American College of Cardiology Conference, March 2006

20

Efficacy of PercuSurge GuardWire system in Acute Myocardial Patients Undergoing Primary/Rescue PCI with a special emphasize on procedural time. Indian Heart Journal, August 2008

21

First-In-Man: PAPIRUS – Monitoring Pulmonary artery Pressure by Implantable device responding to Ultrasonic Signals.  Oral presentation at the Late breaking Clinical Trials Session at ACC-i2 summit, American College of Cardiology Conference, March 2006

22

First-In-Man Implanted Device in Pulmonary Artery Using Acoustic Telemetry Based on Non-invasive Ultrasound Activation and Communication. American College of Cardiology Conference, March 2006 (e-Poster Presentation)

23

Effect of Metoprolol XL on Pulmonary Artery Pressure in Patients with Heart Failure Measured Using First-In-Man Implantable Device Responding to Ultrasonic Signal. J Am Coll Cardiol 2006; 47: 310A.

24

Effect of Metoprolol XL on Diurnal Variation in Pulmonary Artery Pressure Measured Non-invasively Using First-In-Man Implant Responding to Ultrasonic Signals. J Am Coll Cardiol 2006; 47: 370A

25

First-In-Man: Coronary Sinus Narrowing with a Reducer Stent - A Possible Alternative Percutaneous Treatment for Patients with Refractory Angina. J Am Coll Cardiol 2006; 47: 17B

26

Efficacy of PercuSurge GuardWire system in Acute Myocardial Patients Undergoing Primary/Rescue PCI. Oral Presentation at Joint International Conference of ISHR and IACS, Jan 2005, Gujarat, India

27

Associations of White Blood Cell Count with the Occurrence of Slow/No reflow in Acute Coronary Syndrome Patients Undergoing PCI. Poster presentation at Joint International Conference of ISHR and IACS, Jan 2005, Gujarat, India

28

Beneficial Effects of Distal Protection Device in Reducing the Use of Intracoronary Vasodilators and Glycoprotein IIb/IIIa Receptor Antagonists during Percutaneous Coronary Interventions. Presented at Annual Conference of Society of Cardiovascular Angiography and Interventions (SCAI), San Diego, May 2004. Catheter Cardiovasc Interven 2004; 62: pg 90

29

Revascularization in Acute Myocardial Infarction Using PercuSurge in Distal Protection (RAPID).  Presented at Annual Conference of Society of Cardiovascular Angiography and Interventions (SCAI), San Diego, May 2004. Catheter Cardiovasc Interven 2004; 62: pg 116

30

Improvement in MACE by Sequential Administration of Boluses of Intracoronary Adenosine and Sodium Nitroprusside during Percutaneous Coronary Interventions. Presented at Annual Conference of Society of Cardiovascular Angiography and Interventions (SCAI), San Diego, May 2004. Catheter Cardiovasc Interven 2004; 62: pg 130-131

31

Improvement in MACE by Sequential Administration of Boluses of Intracoronary Adenosine and Sodium Nitroprusside during Percutaneous Coronary Interventions. European Society of Cardiology, 2004, Munich, Germany

32

Renal Artery Stenting is Safe and Effective Modality of Treatment on Mid-term Follow-up. Poster presented at 56th Annual Conference of The Cardiological Society of India (CSI) at Bangalore, December 2004

33

Increased Lipoprotien (a) as a Strong Risk Factor for Coronary Artery Disease and the Effect of Niacin Amongst Indians. 56th Annual Conference of The Cardiological Society of India (CSI) at Bangalore, December 2004

34

Effect of Statins in Combination with Fenofibrate in Patients after Percutaneous Transluminal Coronary Angioplasty. Ind J Pharmacol 2004; 36(2): pg 113

35

Pharmaco-epidemiology and Risk Factors of Hypertension in Western Gujarat. Ind J Pharmacol 2003:35(4), pg. 277.

36

Acute Results and Intermediate Term Follow-up of PCI with Cardio-protection by Balloon Occlusion Distal Protection Device. Ind Heart J 2002; 54: 561-568

37
Reversal of Slow-Flow or No-Reflow During PTCA Using Boluses of IC Adenosine and Sodium Nitroprusside, in Combination. J Am Coll Cardiol 2003, Suppl.A to 54:561-568

 

INTERNATIONAL AND  NATIONAL SLIDE PRESENTATIONS
1
    Orbital Atherectomy: Preliminary Experience in Calcific Coronary Artery Disease: C3 Capital Cardiovascular Conference, U.S.A. , Jun 2009
2
Ovalum CiTop: FIM Results and Early Clinical Experience: Chronic Total Occlusion Summit (CTO 2009), U.S.A., Feb 2009
3
First-In-Man Results with the Ovalum CiTopTM ExPander TM Guidewire in Chronic Total Occlusions: Innovations in Cardiovascular Interventions , Israel, Dec 2008
4
Orbital Atherectomy for de novo Calcified Coronary Lesions: The ORBIT I FIM Study: Transcatheter Cardiovascular Therapeutics, Washington DC, U.S.A, Oct 2008
5
Cardiac Pressure Monitoring Devices: Device-based Approaches for Heart Failure II: Emerging Interventional Technologies (REMON): Transcatheter Cardiovascular Therapeutics, Washington DC, U.S.A, Oct 2008
6
Utility and Development of Novel Devices for CTO Applications: The Ovalum CiTop Guidewire System: FIM Coronary CTO Results: Transcatheter Cardiovascular Therapeutics, Washington DC, U.S.A, Oct 2008
7
Revisiting Blunt Microdissection Topic: First-in-Man Results with the Ovalum CiTop  Guidewire System: Chronic Total Occlusion Summit(CTO 2008): New York, Feb 2008
8
New frontiers in Chronic Total Occlusions Topic: CiTopTM  Guidewire - Innovations in Cardiovascular Interventions, Israel, Dec 2007
9
Cardiac Monitoring Devices for CHF - Transcatheter Cardiovascular Therapeutics 2007, Washington, Oct 2007
10
The Ovalum CiTop Guide Wire System - Transcatheter Cardiovascular Therapeutics 2007, Washington, Oct 2007
11
Using the REMON Pressure Device: One year Follow-up — Innovations in Cardiovascular Interventions, Israel, Dec 2006
12
Global Device Evaluation: Can interventions in India Lead the Way —Innovations in Cardiovascular Interventions, Israel, Dec 2006
13
Management of Complex Dyslipidemias — Annual conference of The Cardiology Society of India, Dec 2006
14
Heart Failure: Triumphs and Tribulations - 2006 — Annual  conference of The Cardiology Society of India, Dec 2006
15
PAPIRUS I: One Year Follow-Up of a Novel Pulmonary Artery Implant (and PAPIRUS II Status)—Transcatheter Cardiovascular Therapeutics, Oct 2006
16
Intracoronary Adenosine and Nitroprusside for Slow/No Reflow: From Experimental Preconditioning to Clinical Utility — Transcatheter Cardiovascular Therapeutics, Oct 2006
17
PAPIRUS – Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signals — Annual conference of American College of Cardiology, March 2006
18
Intracoronary Boluses Of Adenosine and Sodium Nitroprusside Combination Reverses Slow/No Reflow During Angioplasty: A Clinical Scenario of Experimental Preconditioning — Annual conference of American College of Cardiology, March 2006
19
First-In-Man Pilot Study using the REMON Ultrasonic Intravascular Sensor to Measure  Pulmonary Artery Pressure — Transcatheter Cardiovascular Therapeutics, 2005.
20
Preliminary Clinical Experience with the NEOVASC Coronary Sinus Reducer Stent — Transcatheter Cardiovascular Therapeutics, 2005

 

CHAPTER IN BOOKS
1
Shah HD, Parikh KH, Goyal RK. Recent Trends in Antiplatelet Therapy for Acute Coronary Syndromes: Glycoprotein IIb/IIIa receptor antagonists: In Pharmacotherapy of Heart Failure by S K Gupta 2005; 102:22 
2
Parikh KH, Shah HD. Stem Cell Therapy in ACS: Type, timing and promise: In The Post Graduate Medicine-2006 (In Press, Scheduled Feb 2006)
3
Parikh KH, et al., Development of Group Practice in Cardiology, Financial planning and Research and development: CSI Book 2005
4
Parikh KH, Shah HD, et al., Stem cell Therapy in ACS; Type, Timing and Promise: AAPI Book, 2006
5
Mehta K N, Parikh K H, Chag MC, Shah U G, Baxi H A, Chandarana A H, Naik A M, Goyal R K, Effect of Folate Treatment on Homocysteinemia in Cardiac Patients: A Prospective Study: Indian Journal of Pharmacology;2005;Vol 37:13-17
6
Parikh KH, Chag MC, Shah UG, Baxi HA, Chandarana AH, Naik AM, Shah HD, Shah JN, Goyal RK; Beneficial effects of addition of fenofibrate to statins In acute coronary syndrome patients undergoing Percutaneous coronary interventions.: World heart Journal

 

 

 

 

   
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