Randomized clinical trial assessing the value of Beta-Blockers and Antiplatelet Agents in patients with Spontaneous Coronary Artery Dissection

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001905-66-ES

Enrollment

600

Registered

2021-06-23

Start date

2021-07-06

Completion date

Unknown

Last updated

2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spontaneous Coronary Artery Dissection

Interventions

Trade Name: Beta-blockers Product Name: Beta-blockers Pharmaceutical Form: Tablet Trade Name: Anti-platelet agents Product Name: Antiplatelet Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

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) - Participation in another clinical trial

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the clinical efficacy of the two most widely used pharmacological therapeutic strategies in patients with SCAD in clinical practice. Namely, to assess the role of beta-blockers and the optimal antiplatelet regimen (short duration of antiplatelet therapy [1 month] versus DAPT for 1 year) in these patients. The consistency of the treatment effect will be examined among 10-predefined relevant clinical variables after adjusting for multiple comparisons.;Secondary Objective: A number of secondary objectives will be also addressed using well-defined predefined ancillary studies: 1) Angiographic and Quantitative Coronary Analyses 2) Coronary revascularization 3) Intracoronary imaging (optical coherence tomography and intravascular ultrasound 4) Cardiac CT 5) Magnetic resonance imaging 6) Pharmacogenetics 7) Inflammatory, immunologic, genetic and micro-RNA analyses;Primary end point(s): Death, MI, stroke, coronary revascularization, recurrent dissection and hospital admission for ACS or heart failure;Timepoint(s) of evaluation of this end point: 1 year	—

Measure

Time frame

Main Objective: To evaluate the clinical efficacy of the two most widely used pharmacological therapeutic strategies in patients with SCAD in clinical practice. Namely, to assess the role of beta-blockers and the optimal antiplatelet regimen (short duration of antiplatelet therapy [1 month] versus DAPT for 1 year) in these patients. The consistency of the treatment effect will be examined among 10-predefined relevant clinical variables after adjusting for multiple comparisons.;Secondary Objective: A number of secondary objectives will be also addressed using well-defined predefined ancillary studies: 1) Angiographic and Quantitative Coronary Analyses 2) Coronary revascularization 3) Intracoronary imaging (optical coherence tomography and intravascular ultrasound 4) Cardiac CT 5) Magnetic resonance imaging 6) Pharmacogenetics 7) Inflammatory, immunologic, genetic and micro-RNA analyses;Primary end point(s): Death, MI, stroke, coronary revascularization, recurrent dissection and hospital admission for ACS or heart failure;Timepoint(s) of evaluation of this end point: 1 year

—

Secondary

Measure	Time frame
Secondary end point(s): Death, MI, stroke, coronary revascularization, and recurrent dissection, hospital admission for ACS or heart failure or bleeding;Timepoint(s) of evaluation of this end point: 1 year	—

Countries

Spain

Contacts

Public ContactGema Cespedes

Spanish Cardiology Society

gcespedes@secardiologia.es+34917242370

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026