Spontaneous Coronary Artery Dissection - AntipLatelet Therapy Intensity in Guided coNservative Management (SCAD-ALIGN) Trial

NCT07683923 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: SCAD-ALIGN-DZHK312025-523985-26-00
• Study Type: interventional
• Target: 3,518
• Locations: 5 countries
• Sites: 5

Brief Summary

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.

Conditions

SCAD; ACS (Acute Coronary Syndrome)

Keywords

SCAD; ACS; APT; MACE; DAPT; spontaneous coronary artery dissection; Antiplatelet therapy

Outcome Measures

Primary Outcomes (1)

• 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

  12 months follow-up

Secondary Outcomes (29)

• First secondary endpoint: MACE (Major Adverse Cardiovascular Events) with cardiovascular mortality

  12 months follow-up

• second secondary endpdoint: NACE (Net adverse clinical events)

  12 months follow-up

• MACE

  3 Months follow-up

• all-cause mortality

  3 months FU

• all-cause mortality

  12 months FU

Study Arms (2)

moderate APT

EXPERIMENTAL

moderate APT therapy, defined as 3 months ASA followed by cessation of APT

Drug: Acetylsalicylic acid ASA

intensive APT

ACTIVE COMPARATOR

intensive APT therapy, defined as 3 months DAPT (ASA + clopidogrel), followed by 9 months of clopidogrel monotherapy

Drug: ASA plus Clopidogrel

Interventions

Acetylsalicylic acid ASA DRUG

3 months ASA monotherapy, dose accoring to international guidelines and local Standard of Care

moderate APT

ASA plus Clopidogrel DRUG

3 months ASA + clopidgrel DAPT, followed by 9 months of clopidogrel monotherapy, doses accoring to international guidelines and local Standard of Care

intensive APT

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years.
• Presentation with an Acute Coronary Syndrome.
• Suspected SCAD on coronary angiography (determined by the local investigator).
• Planned conservative treatment of SCAD.
• Intensive as well as moderate treatment of SCAD is possible.
• Ability to understand the patient information and to personally sign and date the informed consent to participate in the study, before completing any study-related procedures.
• The patient is cooperative and available for the entire study.
• Written and informed consent.
• For women of childbearing potential: Patient is willing to use adequate contraceptive precautions during the study (until 12 Month FU)

You may not qualify if:

• Hypersensitivity to the study medication.
• Any indication for oral anticoagulation.
• Any indication for APT (including thienopyridines, non-thienopyridines, ASA and other anti-thrombotic agents) other than SCAD.
• Cardiogenic shock at the time of screening.
• Coronary artery disease (CAD) requiring secondary preventive therapy with APT.
• Life threatening bleeding (BARC type ≥3) at the time of screening.
• Active bleeding, such as peptic ulcer, tumor bleeding or intracranial hemor-rhage at the time of screening.
• History of major bleeding, BARC class ≥3 within 3 months before study in-clusion.
• Known bleeding diathesis.
• Known coagulopathy or refusal of blood transfusion.
• Planned surgery or intervention at high bleeding risk during the study period.
• Co-administration of contraindicated medications as follows: other P2Y12 inhibitors (prasugrel or ticagrelor); anticoagulants (warfarin, new oral antico-agulants, or chronic therapy with subcutaneous anticoagulants); cytochrome P450 2C19 inhibitors (fluoxetine, moclobemid or voriconazole); probenecid; high dose of methotrexate (≥15 mg/week); lithium.
• Known pregnancy or lactation.
• Current participation in another clinical trial with drugs or medicinal products.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK): collaborator
• Gesellschaft für Therapieforschung mbH: collaborator
• National Institute for Health Research Leicester Biomedical Research Centre, Leicester, UK: collaborator
• Cardio-CARE AG, Davos: collaborator

Study Sites (5)

Division of Cardiology, Vancouver General Hospital, University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

Location

University Medical Center Hamburg-Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

Location

Division of Cardiology, St. Antonius Hospital

Nieuwegein, 3435 CM, Netherlands

Location

Department of Cardiology and Department of Medical and Health Sciences, Linköping University

Linköping, SE-581 83, Sweden

Location

University Hospitals of Leicester NHS Trust

Leicester, LE1 5WW, United Kingdom

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Coronary Artery Dissection, Spontaneous

Interventions

Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Stefan Blankenberg, MD

CONTACT

+49 407410; s.blankenberg@uke.de

Jane A. Leopold, MD

CONTACT

jleopold@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A blinded Clinical Event Committee (CEC) will adjudicate all primary outcome and safety events.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: July 6, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): February 28, 2033
• Study Completion (Estimated): February 28, 2033
• Last Updated: July 6, 2026

Record last verified: 2026-05

Locations

DE (1); CA (1); GB (1); NL (1); SE (1)