About this trial

Spontaneous coronary artery dissection (SCAD) is a cause of acute coronary syndrome (ACS). Most patients are treated with beta-blockers (BB) and antiplatelet drugs (AP) on empiric basis. The Beta-Blockers and Antiplatelet Agents in Patients with Spontaneous Coronary Artery Dissection (BA-SCAD) randomized clinical trial is an academic, pragmatic, nation-wide, prospective study developed under the auspices of the Spanish Society of Cardiology (SEC) that aims to assess the efficacy of medical therapy in SCAD patients. Using a factorial 2x2 design, patients will be randomized (1:1/1:1) to: 1) BB (yes/no) and 2) short AP regimen (1 month) vs prolonged dual AP therapy (DAPT) (12 months).Only patients with preserved left ventricular ejection fraction (LVEF) will be randomized to BB (yes/no) because patients with LVEF \<40% will receive BB according to current guidelines. Likewise, only medically managed patients will be randomized to short AP therapy vs 1-year DAPT. The study will have a pragmatic, open label, blind outcomes design (PROBE). A total of 600 SCAD patients will be randomized within 2 years (300 per arm in a factorial 2x2 design). The primary efficacy endpoint will include the composite of death, acute myocardial infarction (MI), stroke, coronary revascularization, recurrent SCAD, and unplanned hospitalization for ACS or heart failure at 1 year. The primary safety endpoint will be bleeding. All patients will be clinically followed yearly. The main study will be pragmatic but a comprehensive set of additional studies (clinical, imaging, biomarkers, inflammatory, immunologic, pharmacogenetic and genetic) will be organized to ensure an holistic view on this challenging condition.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Angiographic diagnosis of SCAD

Admission for ACS or other manifestations of ischemia

Informed consent

Disqualifiers

Cardiogenic shock or severe hemoynamic instability

Concomitant severe heart disease requiring surgical correction (in <2 years)

Medical condition seriously limiting life expectancy (< 2 years)

Allergies or contraindication to drugs required in one of the study arms; the patient may be randomized in the other arm (factorial design)

Trial design

Design model

Factorial

Treatments tested in this trial

Beta blocker, aspirin, clopidogrel
Drug
Pragmatic design. Beta-blockers and Antiplatelets drugs selected by the investigators. Asprin and Clopidogrel recomended for patients allocated to prologed DAPT. Aspirin Alone recomended for patients allocated to short antiplatelet therapy

Treatment groups

600 Participants

are divided into 4 treatment groups

Group A: Beta-blockers and Short Antiplatelet TherapyExperimental treatment 1 intervention

Group B: Beta-blockers and Long Antiplatelet TherapyExperimental treatment 1 intervention

Group C: No Beta-blockers and Short Antiplatelet TherapyExperimental treatment 1 intervention

Group D: No Beta-blockers and Long Antiplatelet TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

MACE (death, myocardial infarction, coronary revascularization, recurrent SCAD, stroke, unplanned admission for heart failure or acute coronary syndrome with dynamic ECG changes)

Time frame

1 year

Secondary outcomes

1

MACE (death, myocardial infarction, coronary revascularization, stroke and heart failure)

Time frame

1, 2 and 3 years

2

MACE (death, myocardial infarction, coronary revascularization)

Time frame

1, 2 and 3 years

3

MACE (death, myocardial infarction)

Time frame

1, 2 and 3 years

4

MACE (death, myocardial infarction, coronary revascularization, recurrent SCAD, stroke, unplanned admission for heart failure or acute coronary syndrome with dynamic ECG changes)

Time frame

2, 3,4 and 5 years

Other outcomes

1

Substudy on strategies and results of coronary interventions

Strategies and results of coronary interventions (different devices and modalities). Procedural success and angiographic results

Time frame

Through study completion, up to 5 years

2

Substudy on angiographic findings in relation to prognosis

Angiographic analysis (visual and QCA, central corelab). Quantitative coronary angiography analyses (MLD, % diameter stenosis, TIMI Flow)

Time frame

Through study completion, up to 5 years

3

Substudy on value of intracoronary imaging in SCAD (OCT and IVUS)

Intracoronary imaging in SCAD (central corelab) (OCT \[optical coherence tomography\] and IVUS \[intravascular ultrasound\] ). Minimal lumen area.

Time frame

Through study completion, up to 5 years

4

Non-invasive imaging techniques

Cardiac CT and CMR (coronary and peripheral arteries) (central corelab)

Time frame

Through study completion, up to 5 years

Locations

This trial has no locations.

Randomized Study of Beta-Blockers and Antiplatelets in Patients With Spontaneous Coronary Artery Dissection

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Locations

Sponsors and contacts