SCADPhase 4SCAD-ALIGNNCT07683923
Spontaneous Coronary Artery Dissection - AntipLatelet Therapy Intensity in Guided coNservative Management (SCAD-ALIGN) Trial
A Phase 4 study testing Acetylsalicylic acid ASA and ASA plus Clopidogrel in people with SCAD and ACS (Acute Coronary Syndrome), run by Universitätsklinikum Hamburg-Eppendorf at 5 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCAD, ACS (Acute Coronary Syndrome)
- What is being tested?
- Acetylsalicylic acid ASA and ASA plus Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,518 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 1 Mar 2027to 28 Feb 2033
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Presentation with an Acute Coronary Syndrome.
- Suspected SCAD on coronary angiography (determined by the local investigator).
- Planned conservative treatment of SCAD.
- Ability to understand the patient information and to personally sign and date the informed consent to participate in the trial, before completing any trial-related procedures.
- The patient is cooperative and available for the entire trial.
- Written and informed consent.
- 9. For women of childbearing potential: Patient is willing to use adequate contraceptive precautions during the study (until 12 Month FU)
Who cannot join
- Any contraindication to DAPT (ASA and clopidogrel)
- Any indication for APT (including thienopyridines, non-thienopyridines, ASA and other anti-thrombotic agents) other than SCAD.
- Recurrent SCAD within 90 days in the index vessel.
- Known pregnancy
- Current participation in another clinical trial with drugs or medicinal products.
- Previous participation in SCAD-ALIGN
Trial locations and contacts
5 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
Jane A. Leopold, MD contact
5 sites in 5 countries
Canada1 site
Division of Cardiology, Vancouver General Hospital, University of British Columbia
Vancouver, British Columbia, V5Z 1M9
Jacqueline Saw, MD, jsaw@mail.ubc.ca
Germany1 site
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
Christina Magnussen, MD, c.magnussen@uke.de
Netherlands1 site
Division of Cardiology, St. Antonius Hospital
Nieuwegein, 3435 CM
Jurrien M. ten Berg, MD, jurtenberg@gmail.com
Sweden1 site
Department of Cardiology and Department of Medical and Health Sciences, Linköping University
Linköping, SE-581 83
Ewa Swahn, MD, eva.swahn@liu.se
United Kingdom1 site
University Hospitals of Leicester NHS Trust
Leicester, LE1 5WW
David Adlam, MD, da134@le.ac.uk
About this study
Official title: Spontaneous Coronary Artery Dissection - Antiplatelet Therapy Intensity in Guided Conservative Management (SCAD-ALIGN) Trial
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.
Read more
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.
Read the detailed description
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.
- Conditions
- SCAD, ACS (Acute Coronary Syndrome)
- Being tested
- Acetylsalicylic acid ASA, ASA plus Clopidogrel
- Keywords
- SCAD, ACS, APT, MACE, DAPT, spontaneous coronary artery dissection, Antiplatelet therapy
- Medical subject headings
- Acute Coronary Syndrome, Coronary Artery Dissection, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic acid ASADrug
3 months ASA monotherapy, dose accoring to international guidelines and local Standard of Care
ASA plus ClopidogrelDrug
3 months ASA + clopidgrel DAPT, followed by 9 months of clopidogrel monotherapy, doses accoring to international guidelines and local Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| moderate APT | Experimental | moderate APT therapy, defined as 3 months ASA followed by cessation of APT Receives: 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 Receives: Drug: ASA plus Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months follow-up
Secondary outcomes (29)
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
Measured: 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
Measured: 12 months follow-up
MACE
composite endpoint consisting of cardiovascular mortality, myocardial infarction, recurrent SCAD, unplanned coronary revascularization, ischemic stroke, or transient ischemic attack
Measured: 3 Months follow-up
all-cause mortality
Measured: 3 months FU
all-cause mortality
Measured: 12 months FU
cardiovascular mortality
Measured: 3 months FU
cardiovascular mortality
Measured: 12 months FU
myocardial infarction
Measured: 3 months FU
myocardial infarction
Measured: 12 months FU
recurrent SCAD
Measured: 3 months FU
recurrent SCAD
Measured: 12 months FU
unplanned coronary revascularization
Measured: 3 months FU
unplanned coronary revascularization
Measured: 12 months FU
ischemic stroke
Measured: 3 months FU
ischemic stroke
Measured: 12 months FU
transient ischemic attack
Measured: 3 months FU
transient ischemic attack
Measured: 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
Measured: 3 months FU
BARC bleeding type 1, 2, 3 or 5
Measured: 3 months FU
BARC bleeding type 1, 2, 3 or 5
Measured: 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
Measured: 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
Measured: 12 months FU
MACE
composite endpoint consisting of all-cause mortality, myocardial infarction, recurrent SCAD, unplanned coronary revascularization, ischemic stroke, or transient ischemic attack
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Mar 2027 (estimated)
- Primary completion28 Feb 2033 (estimated)
- Study completion28 Feb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCADStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,518 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research Leicester Biomedical Research Centre, Leicester, UK, Gesellschaft für Therapieforschung mbH, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Davos Life Science Pte Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683923
- Sponsor's protocol ID
- SCAD-ALIGN-DZHK31
- Other IDs
- 2025-523985-26-00, 2025
- Acronym
- SCAD-ALIGN
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: to be determined as global study with various stakeholders and country-specific requirements.