Clinical trials: High Ischemic Risk
Cardiovascular Disease, Myocardial Infarction
EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction
The primary objective of this study is to evaluate the effectiveness of early treatment with evolocumab plus routine lipid management vs routine lipid management alone when administered in the acute setting to reduce myocardial…
- Conditions
- Cardiovascular Disease, Myocardial Infarction, Stroke, Coronary Revascularization
- Trial name
- EVOLVE-MI (NCT05284747)
- Testing
- Evolocumab, Routine Lipid Management
- Where
- 120 sites in United States, Brazil and 1 more
- Volunteers
- 6,019 people
- Sponsor
- Amgen
Bleeding Disorder, Stroke, Ischemic
XIENCE 28 Global Study
XIENCE 28 Global Study is a prospective, single arm, multi-center, open label, non-randomized trial to further evaluate the safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of…
- Conditions
- Bleeding Disorder, Stroke, Ischemic, Stroke Hemorrhagic, Hematological Disease
- Trial name
- NCT03355742
- Testing
- XIENCE, DAPT
- Where
- 52 sites in Austria, Belgium and 11 more
- Volunteers
- 963 people
- Sponsor
- Abbott Medical Devices
Non STEMI, Unstable Angina
Safety and Efficacy of CMX-2043 for Protection of the Heart and Kidneys in Subjects Undergoing Coronary Angiography
The objective of this study is to evaluate CMX-2043 for prevention of renal and cardiac injury associated with coronary angiography in patients with acute coronary syndrome (ACS), but excluding ST-elevation myocardial infarction…
- Trial name
- CARIN (NCT02103959)
- Testing
- CMX-2043
- Volunteers
- 361 people
- Sponsor
- Ischemix, LLC
Stable Angina, Ischemic Heart Disease Silent
A Randomized Clinical Evaluation of the BioFreedom™ Stent
The purpose of this study is to demonstrate that a BioFreedom™ Drug Coated Stent is non-inferior to a bare metal stent at one year as measured by the composite safety endpoint of cardiovascular death, myocardial infarction and…
- Conditions
- Stable Angina, Ischemic Heart Disease Silent, ST Elevation (STEMI) and Non-ST Elevation (NSTEMI) Myocardial Infarction, In-stent Coronary Artery Restenosis
- Trial name
- Leaders Free (NCT01623180)
- Testing
- Biofreedom™ Drug Coated Stent (DCS), Gazelle™ Bare Metal Coronary Stent (BMS)
- Where
- Switzerland
- Volunteers
- 2,456 people
- Sponsor
- Biosensors Europe SA
Coronary Artery Disease
Protect II, A Prospective, Multicenter Randomized Controlled Trial
The IMPELLA® 2.5 System will be superior to Intra Aortic Balloon Pump in preventing the composite rate of major adverse events during and after the PCI procedure.
- Trial name
- PROTECT II (NCT00562016)
- Testing
- IMPLELLA LP 2.5, IABP Intra-aortic balloon pump
- Where
- 50 sites in United States, Canada and 1 more
- Volunteers
- 452 people
- Sponsor
- Abiomed Inc.
Coronary Artery Disease
A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients
The purpose of this study is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving…
- Trial name
- Onyx ONE (NCT03344653)
- Testing
- Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Biosensors BioFreedom BA9 Drug Coated Coronary Stent
- Where
- 89 sites in Australia, Austria and 21 more
- Volunteers
- 2,000 people
- Sponsor
- Medtronic Vascular
Hypertension, MTHFR 677 CC or CT Genotype
China Stroke Primary Prevention Trial 2 for Participants With H-type Hypertension and MTHFR 677 CC/CT Genotype (CSPPT2-CC/CT)
This is a multi-center, randomized, double-blind, double-dummy, controlled clinical trial. This trial will include 32,000 Chinese men and women with hypertension (H-type hypertension), MTHFR 677 CC or CT genotype, elevated plasma…
- Conditions
- Hypertension, MTHFR 677 CC or CT Genotype, Elevated Plasma Homocysteine (Hcy≥10µmol/L), Insufficient Plasma Folate Levels (<12ng/mL)
- Trial name
- CSPPT2-CC/CT (NCT04974138)
- Testing
- Amlodipine besylate, Amlodipine besylate and folic acid
- Where
- 20 sites in China
- Volunteers
- 32,000 people
- Sponsor
- Shenzhen Ausa Pharmed Co.,Ltd
Stable Angina (SA), NSTE-ACS (NSTEMI and UA)
Utilisation of Angiox® in European Practice
The objective of this study is to determine utilisation patterns in patients receiving Angiox® in participating European centres.
- Conditions
- Stable Angina (SA), NSTE-ACS (NSTEMI and UA), STEMI (STE-ACS)
- Trial name
- EURO-vision (NCT01011504)
- Where
- 2 sites in France, Germany
- Volunteers
- 2,019 people
- Sponsor
- The Medicines Company
Coronary Artery Disease, Stable Angina Pectoris
A Comparative Evaluation of the Extent of Neointima Formation at 1 Month and 2 Months After Implantation Using OCT
The objective of this study is a comparative evaluation of BuMA Supreme™ stent and of Xience V/Prime stent in terms of the extent of neointima formation at 1 or 2 months after implanting in relatively high bleeding risk patients…
- Conditions
- Coronary Artery Disease, Stable Angina Pectoris, Unstable Angina Pectoris
- Trial name
- NCT02747329
- Testing
- BuMA Supreme™ stent, Xience V/Prime stent
- Where
- China
- Volunteers
- 82 people
- Sponsor
- Sino Medical Sciences Technology Inc.
Coronary Artery Disease, Chronic Stable Angina
LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients
This study aims to demonstrate that the BioFreedom™ Ultra Drug Coated Stent (DCS) is non-inferior to the BioFreedom™ DCS, with respect to in-stent late lumen loss, and that it has safety characteristics similar to the BioFreedom™…
- Conditions
- Coronary Artery Disease, Chronic Stable Angina, Unstable Angina, Silent Ischemia
- Trial name
- NCT06657326
- Testing
- BioFreedom™ Ultra cobalt-chromium Biolimus A9™-coated stent, BioFreedom™ stainless steel Biolimus A9™-coated stent
- Where
- 6 sites in Malaysia
- Volunteers
- 444 people
- Sponsor
- Biosensors Europe SA
Hypercholesterolemia, Coronary Heart Disease
Evaluation of the Efficacy of Rosuvastatin in Daily Practice in Untreated High Risk Patients (CHALLENGE)
In an observational multi-centre study (CHALLENGE), the effects were assessed of starting treatment with low doses of rosuvastatin in statin naive patients with a history of coronary heart disease (CHD), peripheral vascular…
- Conditions
- Hypercholesterolemia, Coronary Heart Disease, Peripheral Vascular Disease, CVA
- Trial name
- CHALLENGE (NCT00574782)
- Volunteers
- 2,660 people
- Sponsor
- AstraZeneca
Coronary Artery Disease
On Versus Off Pump Myocardial Revascularization Study
Compare completeness and modality of revascularization, operative and postoperative results and 1 year clinical outcomes in unselected high risk patients referred for primary coronary artery bypass surgery.
- Trial name
- On-Off (NCT01290952)
- Testing
- Off-pump bypass surgery, On-pump bypass surgery
- Where
- 8 sites in Italy, Switzerland
- Volunteers
- 411 people
- Sponsor
- Medtronic Italia
Patients With History of Ischemic Heart Disease With LV Dysfunction Undergoing Noncardiac Surgery
ACTIONS - Aortic Counterpulsation to Improve Outcomes in Noncardiac Surgery
The use of the IABP, in addition to standard care, in high-risk cardiac patients undergoing major noncardiac surgery is feasible and may result in improved perioperative outcomes at 30 days compared with standard care alone…
- Trial name
- ACTIONS (NCT01253356)
- Testing
- IABP
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Datascope Corp.
Cardiac Death, Myocardial Infarction
Leaders Free III: BioFreedom™ Clinical Trial
A study evaluating the safety and efficacy of the BioFreedom™ Biolimus A9™ coated Cobalt Chromium coronary stent system in patients at high risk of bleeding
- Conditions
- Cardiac Death, Myocardial Infarction, Stent Thrombosis, Bleeding
- Trial name
- NCT03118895
- Testing
- BioFreedom™ BA9™ drug-coated stent
- Where
- 2 sites in France, Switzerland
- Volunteers
- 404 people
- Sponsor
- Biosensors Europe SA
Coronary Artery Disease, High Bleeding Risk Patients
PaneLux PTCA : Proposing an Alternative Treatment to patiEnts for Whom DES Implantation is Not Indicated, Thanks to Pantera LUX Drug Eluting Balloon
The propose of this study is to demonstrate, whenever using Drug Eluting Stent is not possible, the clinical security at 12 months, of the combinaison Bare Metal Stent plus Drug Eluting Balloon.
- Trial name
- PaneLux PTCA (NCT01930903)
- Testing
- Pantera Lux Drug Eluting Balloon
- Where
- France
- Volunteers
- 500 people
- Sponsor
- Biotronik France
Ischemic Stroke; Ischemic Attack, Transient
A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE
The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke.
- Trial name
- LIBREXIA-STROK (NCT05702034)
- Testing
- Milvexian
- Where
- 880 sites in United States, Argentina and 45 more
- Volunteers
- 12,523 people
- Sponsor
- Janssen Research & Development, LLC
Angina, Unstable, Myocardial Infarction
Dalteparin Versus Unfractionated Heparin In Patients With Acute Coronary Syndrome
To compare efficacy and safety of dalteparin compared to unfractionated heparin in patients of non ST elevation acute coronary syndromes who are planned to undergo coronary interventions (angioplasty or bypass surgery)
- Trial name
- NCT00435487
- Testing
- Dalteparin ( Fragmin), Unfractionated heparin
- Where
- 8 sites in India
- Volunteers
- 173 people
- Sponsor
- Pfizer
Cardiovascular Disease
The Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects
This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and…
- Trial name
- SPIRE-2 (NCT01975389)
- Testing
- bococizumab (PF-04950615)
- Where
- 1,595 sites in United States, Argentina and 33 more
- Volunteers
- 10,564 people
- Sponsor
- Pfizer
Coronary Artery Disease
An Open-label, Non-comparative Study to Document the Tolerability to Ramipril in Patients With at Least One High Risk for Developing a Major Cardiovascular Event
Primary Objective: To document the tolerability of patients receiving study medication at 12-week of therapy in terms of the scoring system assessed by the investigator.
- Trial name
- HOPETips (NCT03099213)
- Testing
- RAMIPRIL HOE498
- Where
- Indonesia
- Volunteers
- 179 people
- Sponsor
- Sanofi
Cardiovascular Disease
Length of Effect of Extended Release Aspirin on Platelets in Patients With Diabetes and Heart Disease
This study is being conducted to evaluate the safety and the length of effect on platelet build-up in the arteries of Durlaza™ as compared to immediate-release Bayer® aspirin 81 mg or subject's current aspirin 81 mg of choice in…
- Trial name
- DURATION (NCT02370680)
- Testing
- Aspirin, Durlaza™
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- New Haven Pharmaceuticals, Inc.