NCT04850417Not yet recruitingPhase 4
Randomized Study of Beta-Blockers and Antiplatelets in Patients With Spontaneous Coronary Artery Dissection
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)
Source: ClinicalTrials.gov · Last updated 20 Apr 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 7 Apr 2021
- Start date
- 30 Apr 2021
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Spanish Society of Cardiology
- Diseases
- Coronary artery disease
- NCT number
- NCT04850417
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 600
- From 30 Apr 2021 to the primary completion date, 31 Dec 2024
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant severe heart disease requiring surgical correction (in \<2 years)
Other illness
- Allergies or contraindication to drugs required in one of the study arms; the patient may be randomized in the other arm (factorial design)
Age
- Medical condition seriously limiting life expectancy (\< 2 years)
Other
- Cardiogenic shock or severe hemoynamic instability
Who the study is looking for
- Angiographic diagnosis of SCAD
- Admission for ACS or other manifestations of ischemia
- Informed consent
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.