International Clinical Trials


1

Co – Investigator for RUBY registry (For India) (2002)To evaluate Percusurge / Guardwire Distal Protection Device (Presented by Dr. Aman, Switzerland)

Trial completed

2

Co – Investigator at Sterling Hospital for Extract-TIMI 25 Multicentre multinational Trial (2003)Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction – Study 25.

Trial completed

3

Co – Investigator for  OASIS-5 Trial (2004)To evaluate the efficacy and safety of fondaparinux versus Enoxaparin in the acute treatment of  unstable angina or non ST-segment elevation myocardial infarction acute coronary syndromes.

Trial completed

4

Co – Investigator for  OASIS-6 Trial (2004)To evaluate the efficacy and safety of fondaparinux sodium versus control therapy and Glucose-Insulin-Potassium infusion versus control in broad range in patients with ST – segment elevation acute myocardial infarction.

Trial completed

5

Co – Investigator for TRUST Trial (2004)To evaluate the safety and efficacy of intravenous Remodulin® in patients( in India) With Pulmonary arterial hypertension (PAH) in 12-week.

Trial completed

6

Co – Investigator for Paediatric Hypertension Trial (2005)Dose ranging study to evaluate the  safety and efficacy of Olmesartan medoxomil in children and adolescents with hypertension.

Trial completed

7

Co – Investigator for Hypercholesterol study (NK-104-301) at The Heart Care Clinic (2005)Study of Pitavastatin 2 mg vs. Atorvastatin 10 mg and Pitavastatin 4 mg vs. Atorvastatin 20 mg (Following Up Titration) in Patients with Primary Hypercholesterolemia Or Combined Dyslipidemia.

Trial completed

8

Co – Investigator for Neovasc Reducer™ Pilot Study, First in human: (2005)To evaluate the safety of the Neovasc Reducer™ in the treatment of Ischemic heart Disease (IHD), controlled narrowing of the coronary sinus.

Trial completed

9

Co – Investigator For PAPIRUS Trial: Pilot Study, First in Human: Apollo Hospital (2005)Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal(REMON Device)

Trial completed

10

Co – Investigator for Export study (2006)Flow improvement in patients with Acute Myocardial Infarction undergoing either conventional stenting or a strategy of primary aspiration followed by stenting using the Export® Aspiration Catheter: a Prospective, Randomized, Controlled Study.

Trial completed

11

Co – Investigator for E-five registry (for India) (2006)To Evaluate the ‘Real World’ Clinical Performance of the Medtronic Endeavor™ ABT-578 Eluting Coronary Stent System.

Trial completed

12

Co – Investigator for RELY study (2006)Randomized Evaluation of Long term anticoagulant therapycomparing efficacy and safety of two blinded doses of dabigatran etexilate with open label warfarin for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation: prospective, multi-centre, Parallel group, non-inferiority trial.

Trial completed

13

Co – Investigator for Hypercholesterolemia study (NK-104-307) at The Heart Care Clinic (2006)Open label, long-Term (1year) extension study of Pitavastatin 4 mg QD in patients with Primary Hypercholesterolemia or combined Dyslipidemia.

Trial completed

14

Co – Investigator for  e-SELECT Registry (2007)The e-SELECT Registry: A Multicenter Post Marketing Survelliance.

 Trial completed

15

Co – Investigator for Early ACS trial (2007)Early Glycoprotein Iib/IIIa Inhibition in Non-ST-segment Elevation Acute Coronary Syndrome: A Randomized, Placebo-Controlled Trial Evaluating the Clinical Benefits of Early Front-loaded  Eptifibatide in the Treatment of Patients with Non-ST-segment Elevation Acute Coronary Syndrome (EARLY ACS)

Trial completed

16

Principal  – Investigator  for PLATO trial (2007)A Randomised, Double-blind, Parallel Group, Phase 3, Efficacy and safety study of AZD6140 Compares with Clopidogrel for prevention of Vascular Events in patients with Non-ST or ST Elevation Acute Coronary Syndromes (ACS) [PLATO – A study of PLATelet inhibition and Patient Outcomes.]

Trial completed

17

Co – Investigator  for OASIS- 7 trial (2007)Randomized, multinational, double-blind study, comparing a high loading dose regimen of Clopidogrel versus standard dose in patients with unstable angina or non-ST segment elevation myocardial infarction managed with an early invasive strategy.

Trial completed

18

Co – Investigator  for New Guidewire (2007)First in Man: A Feasibility study to evaluate safety and efficacy of New Guidewire for Crossing Total Occlusions in Coronary Arteries.

Trial completed

19

Co – Investigator for Paediatric Hypertension Trial, The Heart Care Clinic, Ahmedabad (2007)A Randomized, double blind, Placebo-Controlled, Multicenter, Parallel Study Assessing the Efficacy, Safety, and Dose Response of Ramipril for the Treatment of Hypertension in Children and Adolescents.

Trial completed

20

Co – Investigator for Aristotle Trial at The Heart Care Clinic, Ahmedabad (2007)Apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation: Active controlled randomized double blind parallel  arm study to evaluate efficacy and safety of Apixaban in subject with  non valvular Atrial fibrillation.

Follow-ups ongoing

21

Co – Investigator for Rocket Trial at The Heart Care Clinic, Ahmedabad (2007)Multicenter, Randomized, double-blind – dummy, Parallel-group, Non-inferiority Trial Comparing the Efficacy and Safety of Once-daily oral Rivaroxabab (BAY 59-7939) with Adjusted-dose oral Warfarin for the prevention of Stroke and Non-central-nervous-system systemic embolism in Subjects with Non-valvular Atrial Fibrillation.

Follow-ups ongoing

22

Co – Investigator  for PROTECT Trial (2007)Patient Related Outcomes with Endeavor versus Cypher stenting Trial: Prospective, multicenter, randomized, two-arm, open-label trial.

Follow-ups ongoing

23

Co – Investigator  for TMC-CAN-05-02 (2007)A clinical trial comparing Cangrelor to Clopidogrel in subject who require Percutaneous Coronary Intervention.

Follow-ups ongoing

24

Co – Investigator  for TMC-CAN-05-03 (2008)A clinical Trial comparing treatment with Cangrelor (in combination with usual care) to usual care in subjects who require Percutaneous Coronary Intervention.

Follow-ups ongoing

25

Co – Investigator  for CL  (Ivabradine) at The Heart Care Clinic (2008)Evaluation of the anti-anginal efficacy.

Follow-ups ongoing

26

Co – Investigator  for  RE-DEEM at The Heart Care Clinic (2008)Randomized Dabigatran Etexilate dose finding study in patients with acute coronary syndromes post index Event with additional risk factors for cardiovascular complications also receiving aspirin and clopidogrel: Multi-centre, prospective, placebo controlled, group dose escalation trial.

Trial completed

27

Co – Investigator for Magellan Trial (2008)A Multicenter, Randomized, parallel-group efficacy superiority study in hospitalize medically ill patients comparing rivaroxaban with Enoxaparin.

Follow-ups ongoing

28

Co – Investigator for Borealis Trial at The Heart Care Clinic Ahmedabad (2008)A multicenter, randomized, double-blind, assessor-blind, non-inferiority study comparing the efficacy and safety of once-weekly subcutaneous biotinylated idraparinux (SSR126517E) with oral adjusted-dose warfarin in the prevention of stroke and systemic thromboembolic events in patient with atrial fibrillation.

Trial completed

29

Co – Investigator  for Freedom-PAH at The Heart Care ClinicFREEDOM UT – 15C Studies (TDE-PH-302 and TDE-PH-304) conducted by United Therapeutics.

Ongoing

30

Co – Investigator  for ORBIT – 1Pilot study to evaluate the safety & performance or the diamond back 360TM orbit Atherectomy system in treating de-NOVO calcified coronary lesions – orbit -1.

Trial completed

31

Co – Investigator for AVERROES at The Heart Care ClinicCV 185-048: A Phase 3, Active (Aspirin) Controlled, Randomized, Double-Blind, Parallel arm Study to Evaluate the Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation.

Trial completed

32

Co – Investigator  for Red-HF at The Heart Care ClinicA Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Darbepoetin alfa Treatment on Mortality and Morbidity in Heart Failure (HF) Subjects with Symptomatic Left Ventricular Systolic Dysfunction  and Anemia – 20050222 Amendment 1.

Ongoing

33.

Co – Investigator  for TAK-442-202 at The Heart Care ClinicA Phase II, double-blind, Randomized, Placebo-controlled study of the safety and Efficacy of TAK-442 in subjects with Acute Coronary Syndrome.

Trial completed

34.

Co – Investigator  for EISAI-202 at The Heart Care ClinicA Randomized, Double-Blind Placebo controlled study of the safety and tolerability of E5555 and its effect on clinical event and biomarkers in patient with Non ST segment Elevation Acute Coronary Syndrome.

Trial completed

35

Co – Investigator for E-Resolute at the Heart Care ClinicEvaluation of the Endeavor Resolute Zolarolumes-Eluting Coronary Stent System in a ‘Real World’ Patient Population.

Follow-up ongoing

36

Co – Investigator  of RIVAROXABAN at The Heart Care ClinicRandomized, Double Blind, Placebo Controlled, Event Driven, Multi Center Study To Evaluate The Efficacy And Safety Of Rivaroxaban In Subjects With Recent ACS.

Follow-up ongoing

37

Co – Investigator of Pfizer PAH at The Heart Care Clinic B1321001A Phase 3, Multi Center, Randomized, Double Blind, Placebo Controlled, Safety And Efficacy Study Of Sitaxsentan Sodium In Subjects With Pulmonary Arterial Hypertension.

Ongoing

38

Co – Investigator  of Pfizer PAH at The Heart Care Clinic B1321002A Phase 3, Multi Center, Open Label Study To Evaluate The Long Term Safety Of Monotherapy Sitaxsentan Sodium And Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension.

Ongoing

39

Co – Investigator of Pfizer PAH at The Heart Care Clinic B1321003A Phase 3, Multi Center, Randomized, Double Blind, Efficacy And Safety Study Of Monotherapy Sitaxsentan Sodium Versus Combination Therapy With Sitaxsentan Sodium and Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension Who Have Completed Study B1321001.

Ongoing

40

Co – Investigator  of LPL STABILITY at The Heart Care ClinicA Clinical Outcome Study Of Darapladib Versus Placebo In Subjects With Chronic Coronary Heart Disease To Compare The Incidence Of Major Adverse Cardiovascular Event. (MACE)

Follow-up ongoing

41

Co – Investigator  of OASIS-8 at The Heart Care ClinicA Prospective Study Evaluating The Safety Of Two Regimens Of Adjustive Intravenous UFH PCI In High Risk Patients With UA/NSTEMI Initially Treated With Subcutaneous Fondaparinux And Referred For Early Coronary Angiography.

Follow-up ongoing

42

Co – Investigator of STEM CELLA Randomized, Double Blind, Multi Centric, Placebo Controlled, Single Dose, Phase I/II Study Assessing The Safety And Efficacy Of Intravenous Ex Vivo Cultured Adult Allogenic Mesenchymal Stem Cell In Patients With ST Elevated Acute MI  (STEMI) Patient.

Follow-up ongoing

44

Co – Investigator  for RUBY 1 Trial at The Heart Care Clinic Ahmedabad (2010)A Randomized, Double Blind, Placebo Controlled, Multi Center and Parallel Group Study of the Safety, Tolerability, and Efficacy of YM150 in combination with  Standard Treatment in Secondary Prevention of Ischemic Vascular Events in Subjects with Acute Coronary Syndromes.

Follow-up ongoing

45

Co – Investigator  for AmarinTrial at The Heart Care Clinic Ahmedabad (2010)A phase 3, multicenter, placebo controlled, randomized, double blind, 12 week study with an open label extension to evaluate the efficacy And safety of AMR101 in patients with fasting triglyceride levels > 500 mg/dl and < 2000 mg/dl.

Follow-up ongoing

46

Co – Investigator  for SASHF RTrial at The Heart Care Clinic Ahmedabad (2008)South Asian Systolic Heart Failure Registry.

Ongoing

47

Co – Investigator   for TRAC HF Trial at The Heart Care Clinic Ahmedabad (2009)TRAC HF: Ambulatory Monitoring Using External Physiological Sensors in Heart Failure Patients.

Ongoing

48

Co – Investigator for Alecardio trial at CIMS hospitalCardiovascular outcomes study  to evaluate the potential of aleglitazar  to reduce reduce  cardiovascular  risk in patients with  recent acute coronary syndrome (ACS) event and type 2 diabetes mellitus (T2D)

Ongoing

49

Co – Investigator for Timi 52 trial at CIMS hospitalA Clinical Outcomes Study of Darapaladib versus Pleacebo in Subjects Following  Acute Coronary Syndrome  to Compare the Incidence of Major Adverse Cardiovascular Events (MACE)

Ongoing

50

Co – Investigator for Resolute Asia trial at CIMS hospitalEvaluation of the Endevor Resolute Zotarolimus-Eluting Coronary Stent System in a Patient Population with Long Lesion(s) aand/or Dual Vessels in Asia; Prospective, Multi-center, Non-randomized Study.

Ongoing

51

Co – Investigator for Appraise-2 trialA Phase 3, Randomized, Double-blind, Evaluation of the safety and Efficacy of Apixaban in subjects with a Recent Acute Coronary Syndrome.

Follow-up ongoing

National Clinical Trials

1Co – Investigator for BIVAFLO Registy (2006)To evaluate the efficacy and safety of BIVAFLO® as an adjunctive therapy during PCI in moderate-high risk ACS patients with provisional GP IIb/IIIa inhibitors use.Trial completed
2Co – Investigator for CORREL + C Trial (2006)The COREL C Registry: A multicentre Post marketing Survelliance for clinical and angiographic evaluation of Corel C stent.Trial completed
3Principal Investigator for POLYCAP Trial at VS hospital Ahmedabad(2007)A randomized double blind controlled trial of the efficacy And safety of POLYCAP Vs its components in subjects With atleast one additional cardiovascular risk factor.Trial completed
4Co – Investigator for ACUNOVA Trial (2006-2007)A phase III, open label, multicentric, parallel group, Randomized study to evaluate the safety and efficacy of Abciximab in Indian patients scheduled for Percutaneuos Coronary Intervention.Trial completed
5Co – Investigator for ZYHI Trial at The Heart Care Clinic Ahmedabad (2007).(1) A randomized, double blind parallel group, prospective dose ranging study of ZYH 1 with an open fenofibrate arm to evaluate the efficacy on dyslipidemia in patients without diabetes Protocol No. 2001 Ver: 01 (2) A randomized, double blind parallel group, prospective dose ranging study of ZYH1 with an open pioglitazone arm to evaluate the efficacy on dyslipidemia in patients with diabetes Protocol No. 2003 Ver: 02 (3) A randomized, double blind parallel group, prospective dose ranging study of ZYH 1 with an open pioglitazone arm to evaluate the efficacy on dyslipidemia in patients with impaired glucose test Protocol No.2004 Ver: 02.Trial completed

Dr. Anish Chandarana, MD, DM (Cardiology, Gold Medalist) – Senior Cardiologist at CIMS Hospital in Ahmedabad, Gujarat, India +91 9825096922.
Based on the above merits, accomplishments, and detailed resume, as well as from patient feedback across many years, Dr. Anish Chandarana is considered as one of the best cardiologists in Ahmedabad, Gujarat and India.