Microvascular Coronary Artery Disease Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled Parallel Arm Dose Titration Study to Assess the Effects of SAR407899 in Patients With Microvascular Angina (MVA) and/or Persistent Stable Angina Despite Angiographically Successful Percutaneous Coronary Intervention (PCI)
Primary Objective: To assess the effects of SAR407899 on coronary vasomotor function using the coronary flow reserve (CFR) in participants with microvascular angina (MVA) and/or persistent stable angina despite angiographically successful percutaneous coronary intervention (PCI). Secondary Objectives: - To assess the effects of SAR407899 on quality of life using Seattle Angina Questionnaire physical limitation scale (SAQ-PL) in participants with MVA and/or persistent stable angina despite angiographically successful PCI. - To assess the safety of SAR407899 in participants with MVA and/or persistent stable angina despite angiographically successful PCI with a focus on identified risks such as hypotension and orthostatic hypotension. - To assess SAR407899 plasma concentrations in MVA participants and/or persistent stable angina despite angiographically successful PCI.
The total duration of study per participant was: - up to 9 weeks for participants with previous coronary artery angiography or coronary computed tomography angiography (CCTA) within 24 months prior to screening with up to 4 weeks screening period, 3 weeks titration phase, 1 week maintenance period, and 1 week follow-up after the last investigational medicinal product administration. or - up to 11 weeks for participants with previous coronary artery angiography or CCTA between 24 months and 5 years prior to screening who need CCTA during screening period with up to 6 weeks screening period, 3 weeks titration phase, 1 week maintenance period, and 1 week follow-up after the last investigational medicinal product administration. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT04069234 -
Study in Diabetes Mellitus Patients Without Prior Myocardial Infarction or Stroke Undergoing Elective Percutaneous Coronary Intervention.
|
Phase 3 | |
| Recruiting |
NCT04560829 -
Additive Value of Physiology Coronary in Clinical Practice
|
||
| Recruiting |
NCT06080919 -
Plaque Modification And Impact On Microcirculatory Territory After Drug-Coated Balloon Percutaneous Coronary Intervention (PLAMI).
|
N/A | |
| Terminated |
NCT04614467 -
A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction
|
Phase 2 | |
| Recruiting |
NCT04598308 -
EUROpean Coronary microCirculatory Resistance and Absolute Flow Trial
|
||
| Recruiting |
NCT04541797 -
Stress Cardiac Magnetic Resonance of Asymptomatic Type 2 Diabetics With Cardiovascular High Risk to Measure Empagliflozin Impact on Myocardial Blood Flow (CATCH-EM)
|
N/A | |
| Active, not recruiting |
NCT05197361 -
Microvascular Coronary Resistance and Absolute Coronary FLOW in Patients With Percutaneous Intervention of a Chronic Total Occlusion
|
||
| Recruiting |
NCT04827498 -
Myocardial Ischemia Without Obstructive Coronary Stenoses
|
||
| Suspended |
NCT05756088 -
Determining the Association of Microvascular Disease as Assessed by PET and Graft Injury by Donor Derived Cell Free DNA
|
||
| Recruiting |
NCT06118450 -
Clinical Trial for Evaluating the Effectiveness and Safety of Online caIMR in STEMI Patients
|
||
| Recruiting |
NCT03217227 -
Evaluating Myocardial Ischemia in Chest Pain Using Exercise CMR
|
||
| Completed |
NCT03462017 -
Pharmacodynamic Study to Assess the Effects of Repeated Dosing of SAR247799 on Endothelial Function in Patients With Type 2 Diabetes Mellitus
|
Phase 1 | |
| Not yet recruiting |
NCT06269874 -
Study Comparing Two Administration Pathways for Adenosine During Microvascular Function Assessment
|
N/A | |
| Not yet recruiting |
NCT06217120 -
Reversing Microvascular Dysfunction in Heart Failure With Preserved Ejection Fraction
|
Phase 2/Phase 3 | |
| Recruiting |
NCT06316661 -
CMR Assessment of Cardiac Microvascular Dysfunction in Patients With HFpEF
|
||
| Recruiting |
NCT04131075 -
The Cerebral-Coronary Connection (C3) Study
|
||
| Completed |
NCT04485234 -
Inclusive Invasive Physiological Assessment in Angina Syndromes Registry
|
||
| Completed |
NCT05471739 -
Simultaneous Assessment of Coronary Microvascular Dysfunction and Ischemia With Non-obstructed Coronary Arteries With Intracoronary Electrocardiogram and Intracoronary Doppler
|
||
| Completed |
NCT05406297 -
Impact of TMAO Serum Levels on Hyperemic IMR in STEMI Patients
|
||
| Not yet recruiting |
NCT06069401 -
The MASTER-PACT Study
|