Spontaneous coronary artery dissection (SCAD) is a rare cause of acute coronary syndrome in which blood flow to the heart muscle is reduced or interrupted. It predominantly affects women between 30 and 55 years of age and typically occurs in the absence of atherosclerosis. For many years, SCAD remained underdiagnosed and has only recently been more systematically recognised. The SCAD-ALIGN trial will be the first randomised study to systematically compare two antiplatelet treatment strategies in patients with SCAD. SCAD is usually not associated with significant atherosclerosis or the classic vessel occlusion caused by a blood clot. Instead, bleeding occurs within the wall of a coronary artery, causing the vessel layers to separate and thereby impairing or completely obstructing blood flow. Patients develop symptoms of acute myocardial infarction, such as chest pain, shortness of breath, or nausea. A characteristic feature is that these symptoms often occur in individuals without a prior history or risk of heart disease. Platelets play a crucial role in blood clotting but can also accumulate inside blood vessels and further impair flow. Antiplatelet medications are used to prevent this. In current clinical practice, SCAD patients are often treated according to general guidelines for acute coronary syndrome, which typically include two different antiplatelet therapies, a strategy developed and tested in older patients with proven atherosclerosis. The SCAD-ALIGN trial is based on a fundamental difference between SCAD and classic heart attacks. In typical heart attacks, a blood clot usually blocks a vessel, and after the implantation of a vascular support device ("stent"), intensive antiplatelet therapy is used to prevent further clot formation. In SCAD, however, the underlying problem is a tear or bleeding within the vessel wall. In this situation, intensive antiplatelet therapy could delay the resolution of the bleeding or even worsen it, thereby adversely affecting the course of the disease. The study will therefore investigate whether a less intensive treatment strategy may be more beneficial in these patients. The SCAD-ALIGN trial compares two treatment strategies: moderate antiplatelet therapy with a single medication for three months versus more intensive therapy with two agents for three months, followed by nine months of treatment with a single medication. The primary endpoint is a composite of recurrent myocardial ischemia, recurrent SCAD, myocardial infarction, the need for revascularization, and death. The SCAD-ALIGN trial is part of the Multinational Clinical Trials Initiative of the Global Cardiovascular Research Funders Forum (GCRFF). The study is designed as an international, multicentre, randomised, open-label clinical trial. Because SCAD is a rare condition, close collaboration across national borders is essential. The results are expected to make an important contribution to the development of evidence-based treatment recommendations for SCAD, improve care and quality of life for patients worldwide.
Spontaneous Coronary Artery Dissection (SCAD) is an important cause of acute coronary syndromes (ACS), predominantly in younger women. Evidence to guide optimal antiplatelet therapy is limited. Although dual antiplatelet therapy (DAPT) is commonly prescribed, observational studies have linked DAPT to higher rates of adverse cardiovascular events in conservatively managed SCAD. The SCAD-ALIGN trial is an international, prospective, randomized, open-label, group-sequential adaptative, blinded endpoint-adjudicated with two-parallel groups, multicenter trial comparing an intensive APT strategy versus a moderate APT strategy in patients with ACS due to SCAD who are treated conservatively, i.e., without revascularization. The SCAD-ALIGN study will define the benefit-risk balance of these strategies, inform international guideline committees, and clarify optimal treatment strategies. To demonstrate the superiority of a moderate intensity APT strategy compared to an intensive treatment regimen in patients presenting with an ACS caused by SCAD with planned conservative management with regard to major adverse cardiovascular events (MACE), a composite endpoint consisting of all-cause mortali-ty, myocardial infarction, recurrent SCAD, unplanned coronary revascularization, ischemic stroke, or transient ischemic attack 12 months after randomization was chosen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
3,518
3 months ASA monotherapy, dose accoring to international guidelines and local Standard of Care
3 months ASA + clopidgrel DAPT, followed by 9 months of clopidogrel monotherapy, doses accoring to international guidelines and local Standard of Care
Division of Cardiology, Vancouver General Hospital, University of British Columbia
Vancouver, British Columbia, Canada
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, Germany
Division of Cardiology, St. Antonius Hospital
Nieuwegein, Netherlands
Department of Cardiology and Department of Medical and Health Sciences, Linköping University
Linköping, Sweden
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
MACE (Major Adverse Cardiovascular Events) with all-cause-mortality
MACE as a composite of all-cause mortality, myocardial infarction, recurrent SCAD, unplanned coronary revascularization, ischemic stroke, or transient is-chemic attack
Time frame: 12 months follow-up
First secondary endpoint: MACE (Major Adverse Cardiovascular Events) with cardiovascular mortality
Composite endpoint consisting of cardiovascular mortality, myocardial infarction, recurrent SCAD, unplanned coronary revascularization, ischemic stroke, or transient ischemic attack
Time frame: 12 months follow-up
second secondary endpdoint: NACE (Net adverse clinical events)
composite of cardiovascular mortality, myocardial infarction, recurrent SCAD, unplanned coronary revascularization, ischemic stroke or transient ischemic attack and Bleeding aca-demia research consortium (BARC) bleeding types 3 or 5
Time frame: 12 months follow-up
MACE
composite endpoint consisting of cardiovascular mortality, myocardial infarction, recurrent SCAD, unplanned coronary revascularization, ischemic stroke, or transient ischemic attack
Time frame: 3 Months follow-up
all-cause mortality
Time frame: 3 months FU
all-cause mortality
Time frame: 12 months FU
cardiovascular mortality
Time frame: 3 months FU
cardiovascular mortality
Time frame: 12 months FU
myocardial infarction
Time frame: 3 months FU
myocardial infarction
Time frame: 12 months FU
recurrent SCAD
Time frame: 3 months FU
recurrent SCAD
Time frame: 12 months FU
unplanned coronary revascularization
Time frame: 3 months FU
unplanned coronary revascularization
Time frame: 12 months FU
ischemic stroke
Time frame: 3 months FU
ischemic stroke
Time frame: 12 months FU
transient ischemic attack
Time frame: 3 months FU
transient ischemic attack
Time frame: 12 months FU
NACE
composite of cardiovascular mortality, myocardial infarction, recurrent SCAD, unplanned coronary revascularization, ischemic stroke or transient ischemic attack and BARC bleeding types 3 or 5
Time frame: 3 months FU
BARC bleeding type 1, 2, 3 or 5
Time frame: 3 months FU
BARC bleeding type 1, 2, 3 or 5
Time frame: 12 months FU
Menorrhagia associated quality of life
assessed with Menorrhagia multi-attribute scale (MMAS), consisting of 6 dimensions with 4-level Likert scale for responses
Time frame: 3 months FU
Menorrhagia associated quality of life
assessed with Menorrhagia multi-attribute scale (MMAS), consisting of 6 dimensions with 4-level Likert scale for responses
Time frame: 12 months FU
MACE
composite endpoint consisting of all-cause mortality, myocardial infarction, recurrent SCAD, unplanned coronary revascularization, ischemic stroke, or transient ischemic attack
Time frame: 3 Months follow-up
Health-related Quality of Life
assessed with EQ5D-5L questionnaire, consisting of 5 domains with 5-level Likert scale and a visual analogue self-rating scale (VAS) from 0 (worst) to 100 (best)
Time frame: 3 months FU
Health-related Quality of Life
assessed with EQ5D-5L questionnaire, consisting of 5 domains with 5-level Likert scale and a visual analogue self-rating scale (VAS) from 0 (worst) to 100 (best)
Time frame: 12 months FU
Patient Health Questionnaire PHQ-8
self-administered version of the Primary Care Evaluation of Mental Disorders diagnostic Instrument for common mental disorders. The PHQ-8 is the depression module, which scores each of the 8 diagnostic criteria for major depression in Diagnostic and Statistical Manual Fourth Edition using a 4-level Likert scale
Time frame: 3 months FU
Patient Health Questionnaire PHQ-8
self-administered version of the Primary Care Evaluation of Mental Disorders diagnostic Instrument for common mental disorders. The PHQ-8 is the depression module, which scores each of the 8 diagnostic criteria for major depression in Diagnostic and Statistical Manual Fourth Edition using a 4-level Likert scale
Time frame: 12 months FU
Generalized Anxiety Disorder (GAD-7) questionnaire
screening tool to identify probable cases of GAD and to assess symptom severity. 7 items and 4-level Likert-scale
Time frame: 3 months FU
Generalized Anxiety Disorder (GAD-7) questionnaire
screening tool to identify probable cases of GAD and to assess symptom severity. 7 items and 4-level Likert-scale
Time frame: 12 months FU
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.