A Phase 4 interventional study of Beta blocker, aspirin, clopidogrel in Spontaneous Coronary Artery Dissection, sponsored by Spanish Society of Cardiology. Not yet recruiting. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-04-20.
Sponsored by Spanish Society of Cardiology · Phase 4, Interventional, and Treatment
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.
Spontaneous coronary artery dissection (SCAD) is a relatively rare but important and increasingly recognized cause of acute coronary syndrome (ACS). Most patients presenting with SCAD are treated with beta-blockers (BB) and antiplatelet drugs (AP). Although appealing from a pathophysiological standpoint, such management strategy is completely empiric. 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). A conservative medical management will be initially recommended, with coronary revascularization reserved for patients with ongoing/refractory ischemia. 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, because patients requiring coronary interventions will receive DAPT. The study will have a pragmatic, open label, blind outcomes design (PROBE). The type and dose of BB and AP agents will be at the discretion of the treating physician. Treatment adherence will be reinforced and closely monitored and the potential influence of drug discontinuation/cross-over on outcomes will be carefully evaluated. 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 hospital admission for ACS or heart failure at 1 year. The primary safety endpoint will be bleeding according the Bleeding Academic Research Consortium (BARC) criteria ≥ 3. An analysis of net clinical benefit, including primary efficacy and safety endpoints, will also be performed. All patients will be clinically followed at 1 year (primary endpoint) and yearly thereafter. Although the main study will be pragmatic, following routine clinical practice, a systematic and comprehensive set of additional ancillary studies and investigations (clinical, imaging, biomarkers, inflammatory, immunologic, pharmacogenetic and genetic) will be prospectively organized to ensure a multidisciplinary and holistic view on this challenging condition.
385 studies on the registry are indexed under Aortic Dissection; 117 are open to participants now.
This study's planned enrollment of 600 is above the median of 84 across 198 interventional studies indexed under Aortic Dissection.
Browse Aortic Dissection studies →Spanish Society of Cardiology is the lead sponsor of 23 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Beta-blockers (experimental) and Short Antiplatelet Therapy (experimental). Aspirin alone recommended for Short Antiplatelet Therapy (The main comparison of this randomized clinical trial (2x2, factorial design) is beta-blockers vs no beta-blockers and short vs long-term antiplatelet therapy)
Drug: Beta blocker, aspirin, clopidogrel
Beta-blockers (experimental) and Long Antiplatelet Therapy. Aspirin and Clopidogrel recommended in Long Antiplatelet Therapy (The main comparison of this randomized clinical trial (2x2, factorial design) is beta-blockers vs no beta-blockers and short vs long-term antiplatelet therapy)
Drug: Beta blocker, aspirin, clopidogrel
No Beta-blockers and Short Antiplatelet Therapy (experimental). Aspirin alone recommended in Short Antiplatelet Therapy (The main comparison of this randomized clinical trial (2x2, factorial design) is beta-blockers vs no beta-blockers and short vs long-term antiplatelet therapy)
Drug: Beta blocker, aspirin, clopidogrel
No Beta-blockers and Long Antiplatelet Therapy. Aspirin and Clopidogrel recommended in Long Antiplatelet Therapy (The main comparison of this randomized clinical trial (2x2, factorial design) is beta-blockers vs no beta-blockers and short vs long-term antiplatelet therapy)
Drug: Beta blocker, aspirin, clopidogrel
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
Also known as: Beta-blockers, Aspirin, Clopidogrel
MACE (death, myocardial infarction, coronary revascularization, recurrent SCAD, stroke, unplanned admission for heart failure or acute coronary syndrome with dynamic ECG changes)
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
MACE (death, myocardial infarction, coronary revascularization, stroke and heart failure)
MACE (death, myocardial infarction, coronary revascularization, stroke and heart failure)
Time frame: 1, 2 and 3 years
MACE (death, myocardial infarction, coronary revascularization)
MACE (death, myocardial infarction, coronary revascularization)
Time frame: 1, 2 and 3 years
MACE (death, myocardial infarction)
MACE (death, myocardial infarction)
Time frame: 1, 2 and 3 years
MACE (death, myocardial infarction, coronary revascularization, recurrent SCAD, stroke, unplanned admission for heart failure or acute coronary syndrome with dynamic ECG changes)
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
Safety: Major Bleeding
Major Bleeding (BARC \>=3)
Time frame: 1 year
Safety: Bleeding
Bleeding (BARC \>=2)
Time frame: 1 year
MACE and Bleeding
MACE (death, myocardial infarction, coronary revascularization, recurrent SCAD, stroke, unplanned admission for heart failure or acute coronary syndrome with dynamic ECG changes) and bleeding
Time frame: 1, 2 and 3 years
Death
Death
Time frame: 1, 2 and 3 years
Myocardial infarction
Myocardial infarction
Time frame: 1, 2 and 3 years
Coronary revascularization
Coronary revascularization
Time frame: 1, 2 and 3 years
Recurrent SCAD
Recurrent SCAD
Time frame: 1, 2 and 3 years
Stroke
Stroke
Time frame: 1, 2 and 3 years
Unplanned admission for heart failure
Unplanned admission for heart failure
Time frame: 1, 2 and 3 years
Unplanned admission for acute coronary syndrome with dynamic ECG changes
Unplanned admission for acute coronary syndrome with dynamic ECG changes
Time frame: 1, 2, 3 years
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
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
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
Non-invasive imaging techniques
Cardiac CT and CMR (coronary and peripheral arteries) (central corelab)
Time frame: Through study completion, up to 5 years
Substudy on inflammation and biomarkers
Comprehensive analysis of biomarkers. Coordinating center (HULP). Including leucocytes, HsCRP, IL6
Time frame: Through study completion, up to 5 years
Pharmacogenomic study
Pharmacogenomic study. Coordinating center (HULP). Percent of responders to treatment according to the pharmacogenomic profile
Time frame: Through study completion, up to 5 years
Micro RNAs and Genetic studies
Micro RNAs and Genetic studies. Coordinating center (HULP). Array of different micro-RNAs
Time frame: Through study completion, up to 5 years
No study locations are listed for this record.
Plan to share: Yes — To be decided by the steering committee upon formal official request by academic investigators
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is not yet recruiting, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Spanish Society of Cardiology