Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04850417
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-04-20
First Post:
2021-04-07
Brief Title:
Randomized Study of Beta-Blockers and Antiplatelets in Patients With Spontaneous Coronary Artery Dissection
Sponsor:
Spanish Society of Cardiology
Organization:
Spanish Society of Cardiology
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BA-SCAD
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 1111 to 1 BB yesno and 2 short AP regimen 1 month vs prolonged dual AP therapy DAPT 12 monthsOnly patients with preserved left ventricular ejection fraction LVEF will be randomized to BB yesno 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
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 1111 to 1 BB yesno 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 ongoingrefractory ischemia Only patients with preserved left ventricular ejection fraction LVEF will be randomized to BB yesno 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 discontinuationcross-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None