Randomized clinical trial assessing the value of Beta-Blockers and Antiplatelet Agents in patients with Spontaneous Coronary Artery Dissection (BA-SCAD).
Phase 1
Active, not recruiting
- Conditions
- Spontaneous Coronary Artery Dissection.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2024-516039-28-00
- Lead Sponsor
- Spanish Society Of Cardiology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 700
Inclusion Criteria
Written informed consent., Patients admitted for ACS or any other manifestation of myocardial ischemia., Diagnosis of SCAD on a coronary angiography during index hospitalization.
Exclusion Criteria
Cardiogenic shock or severe hemodynamic instability., Concomitant severe heart disease requiring surgical correction (in <2 years)., Any major medical condition seriously limiting life expectancy (<2 years)., Pregnant or breastfeeding women. Child-bearing age women participating in the study will be advised to use a highly effective contraceptive method considering the high-risk of recurrent SCAD associated with pregnancy., Participation in another clinical trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of medical therapy (ß-blockers and antiplatelet agents) in patients with Spontaneous Coronary Artery Dissection (SCAD).;Secondary Objective: Angiographic and Quantitative Coronary Analyses (QCA)., Coronary revascularization (selection of ideal candidates and optimization of results of coronary interventions)., Intracoronary imaging (optical coherence tomography [OCT] and intravascular ultrasound [IVUS]., Cardiac CT., Magnetic resonance imaging (MRI)., Pharmacogenetics., Inflammatory, immunologic, genetic and micro-RNA analyses.;Primary end point(s): A combined clinical endpoint including death, MI, stroke, coronary revascularization, recurrent dissection and hospital admission for ACS or heart failure at 1-year follow-up.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):a secondary combined clinical endpoint (composite of death, MI, stroke, coronary revascularization, and recurrent dissection, hospital admission for ACS –with dynamic ECG changes- or heart failure or bleeding) will be used to assess the net clinical benefit” of the antiplatelet strategy.;Secondary end point(s):Bleeding will be also analyzed as a separate safety secondary endpoint. Bleeding will be defined according to BARC definitions.;Secondary end point(s):Individual components of the primary endpoint will be assessed as secondary endpoints. Besides, a major predefined secondary combined endpoint will be the composite outcome measure of hard” clinical events (including death, MI, stroke, recurrent dissection and coronary revascularization) and the combined outcome measure of death and MI alone.