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

NCT04850417 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: BA-SCAD
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Spontaneous Coronary Artery Dissection

Keywords

Spontaneous coronary artery dissection; Beta-blockers; Antiplatelets; Coronary angiography; Intracoronary imaging; Biomarkers; Myocardial infarction

Outcome Measures

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)

  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 Outcomes (14)

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

  1, 2 and 3 years

• MACE (death, myocardial infarction, coronary revascularization)

  1, 2 and 3 years

• MACE (death, myocardial infarction)

  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)

  2, 3,4 and 5 years

• Safety: Major Bleeding

  1 year

Other Outcomes (7)

• Substudy on strategies and results of coronary interventions

  Through study completion, up to 5 years

• Substudy on angiographic findings in relation to prognosis

  Through study completion, up to 5 years

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

  Through study completion, up to 5 years

Study Arms (4)

Beta-blockers and Short Antiplatelet Therapy

EXPERIMENTAL

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 and Long Antiplatelet Therapy

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

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

Interventions

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

Also known as: Beta-blockers, Aspirin, Clopidogrel

Beta-blockers and Long Antiplatelet Therapy; Beta-blockers and Short Antiplatelet Therapy; No Beta-blockers and Long Antiplatelet Therapy; No Beta-blockers and Short Antiplatelet Therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Angiographic diagnosis of SCAD
• Admission for ACS or other manifestations of ischemia
• Informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Spanish Society of Cardiology: lead
• Instituto de Investigación Sanitaria Hospital Universitario de la Princesa: collaborator
• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa: collaborator

Related Publications (1)

• Alfonso F, de la Torre Hernandez JM, Ibanez B, Sabate M, Pan M, Gulati R, Saw J, Angiolillo DJ, Adlam D, Sanchez-Madrid F. Rationale and design of the BA-SCAD (Beta-blockers and Antiplatelet agents in patients with Spontaneous Coronary Artery Dissection) randomized clinical trial. Rev Esp Cardiol (Engl Ed). 2022 Jun;75(6):515-522. doi: 10.1016/j.rec.2021.08.003. Epub 2021 Sep 22. English, Spanish.

  PMID: 34561195 DERIVED

MeSH Terms

Conditions

Coronary Artery Dissection, Spontaneous; Myocardial Infarction

Interventions

Adrenergic beta-Antagonists; Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Spanish Society of Cardiology Spanish Society of Cardiology

  Spanish Society of Cardiology

  STUDY CHAIR

Central Study Contacts

Fernando Alfonso, MD

CONTACT

34 680483165; falf@hotmail.com

Spanish Society of Cardiology Spanish Society of Cardiology

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Factorial 2x2 design (a) beta-blockers yes/no; b) Antiplatelets short/long)

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 20, 2021
• Study Start: April 30, 2021
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After the primary endpoint is reported
• Access Criteria: To be discussed