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

Spontaneous Coronary Artery Dissection Clinical Trial

— BA-SCAD  

Official title:

Randomized Clinical Trial Assessing the Value of Beta-Blockers and Antiplatelet Agents in Patients With Spontaneous Coronary Artery Dissection. (The BA-SCAD Randomized Clinical Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04850417
• Other study ID #: BA-SCAD
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 30, 2021
• Est. completion date: December 31, 2028

Study information

• Verified date: April 2021
• Source: Spanish Society of Cardiology
• Contact: Fernando Alfonso, MD
• Phone: 34 680483165
• Email: falf[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Angiographic diagnosis of SCAD

• Admission for ACS or other manifestations of ischemia

• Informed consent

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Coronary Vessel Anomalies
• Spontaneous Coronary Artery Dissection
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Spanish Society of Cardiology	Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Hospital Universitario de la Princesa

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Substudy on strategies and results of coronary interventions	Strategies and results of coronary interventions (different devices and modalities). Procedural success and angiographic results	Through study completion, up to 5 years
Other	Substudy on angiographic findings in relation to prognosis	Angiographic analysis (visual and QCA, central corelab). Quantitative coronary angiography analyses (MLD, % diameter stenosis, TIMI Flow)	Through study completion, up to 5 years
Other	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.	Through study completion, up to 5 years
Other	Non-invasive imaging techniques	Cardiac CT and CMR (coronary and peripheral arteries) (central corelab)	Through study completion, up to 5 years
Other	Substudy on inflammation and biomarkers	Comprehensive analysis of biomarkers. Coordinating center (HULP). Including leucocytes, HsCRP, IL6	Through study completion, up to 5 years
Other	Pharmacogenomic study	Pharmacogenomic study. Coordinating center (HULP). Percent of responders to treatment according to the pharmacogenomic profile	Through study completion, up to 5 years
Other	Micro RNAs and Genetic studies	Micro RNAs and Genetic studies. Coordinating center (HULP). Array of different micro-RNAs	Through study completion, up to 5 years
Primary	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)	1 year
Secondary	MACE (death, myocardial infarction, coronary revascularization, stroke and heart failure)	MACE (death, myocardial infarction, coronary revascularization, stroke and heart failure)	1, 2 and 3 years
Secondary	MACE (death, myocardial infarction, coronary revascularization)	MACE (death, myocardial infarction, coronary revascularization)	1, 2 and 3 years
Secondary	MACE (death, myocardial infarction)	MACE (death, myocardial infarction)	1, 2 and 3 years
Secondary	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)	2, 3,4 and 5 years
Secondary	Safety: Major Bleeding	Major Bleeding (BARC >=3)	1 year
Secondary	Safety: Bleeding	Bleeding (BARC >=2)	1 year
Secondary	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	1, 2 and 3 years
Secondary	Death	Death	1, 2 and 3 years
Secondary	Myocardial infarction	Myocardial infarction	1, 2 and 3 years
Secondary	Coronary revascularization	Coronary revascularization	1, 2 and 3 years
Secondary	Recurrent SCAD	Recurrent SCAD	1, 2 and 3 years
Secondary	Stroke	Stroke	1, 2 and 3 years
Secondary	Unplanned admission for heart failure	Unplanned admission for heart failure	1, 2 and 3 years
Secondary	Unplanned admission for acute coronary syndrome with dynamic ECG changes	Unplanned admission for acute coronary syndrome with dynamic ECG changes	1, 2, 3 years