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Randomized Study of Beta-Blockers and Antiplatelets in Patients With Spontaneous Coronary Artery Dissection (BA-SCAD)

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ClinicalTrials.gov Identifier: NCT04850417
Recruitment Status : Not yet recruiting
First Posted : April 20, 2021
Last Update Posted : April 20, 2021
Sponsor:
Collaborators:
Instituto de Investigación Sanitaria Hospital Universitario de la Princesa
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Information provided by (Responsible Party):
Fernando Alfonso, Spanish Society of Cardiology

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.

Condition or disease Intervention/treatment Phase
Spontaneous Coronary Artery Dissection Drug: Beta blocker, aspirin, clopidogrel Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Factorial 2x2 design (a) beta-blockers yes/no; b) Antiplatelets short/long)
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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)
Estimated Study Start Date : April 30, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2028


Arm Intervention/treatment
Experimental: Beta-blockers and Short Antiplatelet Therapy

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
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
Other Names:
  • Beta-blockers
  • Aspirin
  • Clopidogrel

Experimental: Beta-blockers and Long Antiplatelet Therapy

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
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
Other Names:
  • Beta-blockers
  • Aspirin
  • Clopidogrel

Experimental: No Beta-blockers and Short Antiplatelet Therapy

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
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
Other Names:
  • Beta-blockers
  • Aspirin
  • Clopidogrel

Active Comparator: No Beta-blockers and Long Antiplatelet Therapy

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
Other Names:
  • Beta-blockers
  • Aspirin
  • Clopidogrel




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


Secondary Outcome Measures :
  1. MACE (death, myocardial infarction, coronary revascularization, stroke and heart failure) [ Time Frame: 1, 2 and 3 years ]
    MACE (death, myocardial infarction, coronary revascularization, stroke and heart failure)

  2. MACE (death, myocardial infarction, coronary revascularization) [ Time Frame: 1, 2 and 3 years ]
    MACE (death, myocardial infarction, coronary revascularization)

  3. MACE (death, myocardial infarction) [ Time Frame: 1, 2 and 3 years ]
    MACE (death, myocardial infarction)

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

  5. Safety: Major Bleeding [ Time Frame: 1 year ]
    Major Bleeding (BARC >=3)

  6. Safety: Bleeding [ Time Frame: 1 year ]
    Bleeding (BARC >=2)

  7. MACE and Bleeding [ 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) and bleeding

  8. Death [ Time Frame: 1, 2 and 3 years ]
    Death

  9. Myocardial infarction [ Time Frame: 1, 2 and 3 years ]
    Myocardial infarction

  10. Coronary revascularization [ Time Frame: 1, 2 and 3 years ]
    Coronary revascularization

  11. Recurrent SCAD [ Time Frame: 1, 2 and 3 years ]
    Recurrent SCAD

  12. Stroke [ Time Frame: 1, 2 and 3 years ]
    Stroke

  13. Unplanned admission for heart failure [ Time Frame: 1, 2 and 3 years ]
    Unplanned admission for heart failure

  14. Unplanned admission for acute coronary syndrome with dynamic ECG changes [ Time Frame: 1, 2, 3 years ]
    Unplanned admission for acute coronary syndrome with dynamic ECG changes


Other Outcome Measures:
  1. Substudy on strategies and results of coronary interventions [ Time Frame: Through study completion, up to 5 years ]
    Strategies and results of coronary interventions (different devices and modalities). Procedural success and angiographic results

  2. Substudy on angiographic findings in relation to prognosis [ Time Frame: Through study completion, up to 5 years ]
    Angiographic analysis (visual and QCA, central corelab). Quantitative coronary angiography analyses (MLD, % diameter stenosis, TIMI Flow)

  3. Substudy on value of intracoronary imaging in SCAD (OCT and IVUS) [ Time Frame: Through study completion, up to 5 years ]
    Intracoronary imaging in SCAD (central corelab) (OCT [optical coherence tomography] and IVUS [intravascular ultrasound] ). Minimal lumen area.

  4. Non-invasive imaging techniques [ Time Frame: Through study completion, up to 5 years ]
    Cardiac CT and CMR (coronary and peripheral arteries) (central corelab)

  5. Substudy on inflammation and biomarkers [ Time Frame: Through study completion, up to 5 years ]
    Comprehensive analysis of biomarkers. Coordinating center (HULP). Including leucocytes, HsCRP, IL6

  6. Pharmacogenomic study [ Time Frame: Through study completion, up to 5 years ]
    Pharmacogenomic study. Coordinating center (HULP). Percent of responders to treatment according to the pharmacogenomic profile

  7. Micro RNAs and Genetic studies [ Time Frame: Through study completion, up to 5 years ]
    Micro RNAs and Genetic studies. Coordinating center (HULP). Array of different micro-RNAs



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04850417


Contacts
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Contact: Fernando Alfonso, MD 34 680483165 falf@hotmail.com
Contact: Spanish Society of Cardiology Spanish Society of Cardiology

Sponsors and Collaborators
Spanish Society of Cardiology
Instituto de Investigación Sanitaria Hospital Universitario de la Princesa
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Investigators
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Study Chair: Spanish Society of Cardiology Spanish Society of Cardiology Spanish Society of Cardiology
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fernando Alfonso, Principal Investigator, Spanish Society of Cardiology
ClinicalTrials.gov Identifier: NCT04850417    
Other Study ID Numbers: BA-SCAD
First Posted: April 20, 2021    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: To be decided by the steering committee upon formal official request by academic investigators
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: After the primary endpoint is reported
Access Criteria: To be discussed

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fernando Alfonso, Spanish Society of Cardiology:
Spontaneous coronary artery dissection
Beta-blockers
Antiplatelets
Coronary angiography
Intracoronary imaging
Biomarkers
Myocardial infarction
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Coronary Vessel Anomalies
Vascular Diseases
Aneurysm
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities
Aspirin
Clopidogrel
Adrenergic beta-Antagonists
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists