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

2026년 6월 28일 업데이트: Universitätsklinikum Hamburg-Eppendorf

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.

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

3518

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 네덜란드
      • Nieuwegein, 네덜란드, 3435 CM
        • Division of Cardiology, St. Antonius Hospital
        • 연락하다:
  • 독일
    • Free and Hanseatic City of Hamburg
      • Hamburg, Free and Hanseatic City of Hamburg, 독일, 20246
        • University Medical Center Hamburg-Eppendorf
        • 연락하다:
  • 스웨덴
      • Linköping, 스웨덴, SE-581 83
        • Department of Cardiology and Department of Medical and Health Sciences, Linköping University
        • 연락하다:
  • 영국
      • Leicester, 영국, LE1 5WW
        • University Hospitals of Leicester NHS Trust
        • 연락하다:
  • 캐나다
    • British Columbia
      • Vancouver, British Columbia, 캐나다, V5Z 1M9
        • Division of Cardiology, Vancouver General Hospital, University of British Columbia
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  1. Age ≥18 years.
  2. Presentation with an Acute Coronary Syndrome.
  3. Suspected SCAD on coronary angiography (determined by the local investigator).
  4. Planned conservative treatment of SCAD.
  5. Intensive as well as moderate treatment of SCAD is possible.
  6. 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.
  7. The patient is cooperative and available for the entire study.
  8. 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)

Exclusion Criteria:

  1. Hypersensitivity to the study medication.
  2. Any indication for oral anticoagulation.
  3. Any indication for APT (including thienopyridines, non-thienopyridines, ASA and other anti-thrombotic agents) other than SCAD.
  4. Cardiogenic shock at the time of screening.
  5. Coronary artery disease (CAD) requiring secondary preventive therapy with APT.
  6. Life threatening bleeding (BARC type ≥3) at the time of screening.
  7. Active bleeding, such as peptic ulcer, tumor bleeding or intracranial hemor-rhage at the time of screening.
  8. History of major bleeding, BARC class ≥3 within 3 months before study in-clusion.
  9. Known bleeding diathesis.
  10. Known coagulopathy or refusal of blood transfusion.
  11. Planned surgery or intervention at high bleeding risk during the study period.
  12. 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.
  13. Known pregnancy or lactation.
  14. Current participation in another clinical trial with drugs or medicinal products.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: moderate APT
moderate APT therapy, defined as 3 months ASA followed by cessation of APT
의약품: Acetylsalicylic acid ASA
3 months ASA monotherapy, dose accoring to international guidelines and local Standard of Care
활성 비교기: intensive APT
intensive APT therapy, defined as 3 months DAPT (ASA + clopidogrel), followed by 9 months of clopidogrel monotherapy
의약품: ASA plus Clopidogrel
3 months ASA + clopidgrel DAPT, followed by 9 months of clopidogrel monotherapy, doses accoring to international guidelines and local Standard of Care

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
MACE (Major Adverse Cardiovascular Events) with all-cause-mortality
기간: 12 months follow-up
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

2차 결과 측정

결과 측정
측정값 설명
기간
First secondary endpoint: MACE (Major Adverse Cardiovascular Events) with cardiovascular mortality
기간: 12 months follow-up
Composite endpoint consisting of cardiovascular mortality, myocardial infarction, recurrent SCAD, unplanned coronary revascularization, ischemic stroke, or transient ischemic attack
12 months follow-up
second secondary endpdoint: NACE (Net adverse clinical events)
기간: 12 months follow-up
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
12 months follow-up
MACE
기간: 3 Months follow-up
composite endpoint consisting of cardiovascular mortality, myocardial infarction, recurrent SCAD, unplanned coronary revascularization, ischemic stroke, or transient ischemic attack
3 Months follow-up
all-cause mortality
기간: 3 months FU
3 months FU
all-cause mortality
기간: 12 months FU
12 months FU
cardiovascular mortality
기간: 3 months FU
3 months FU
cardiovascular mortality
기간: 12 months FU
12 months FU
myocardial infarction
기간: 3 months FU
3 months FU
myocardial infarction
기간: 12 months FU
12 months FU
recurrent SCAD
기간: 3 months FU
3 months FU
recurrent SCAD
기간: 12 months FU
12 months FU
unplanned coronary revascularization
기간: 3 months FU
3 months FU
unplanned coronary revascularization
기간: 12 months FU
12 months FU
ischemic stroke
기간: 3 months FU
3 months FU
ischemic stroke
기간: 12 months FU
12 months FU
transient ischemic attack
기간: 3 months FU
3 months FU
transient ischemic attack
기간: 12 months FU
12 months FU
NACE
기간: 3 months FU
composite of cardiovascular mortality, myocardial infarction, recurrent SCAD, unplanned coronary revascularization, ischemic stroke or transient ischemic attack and BARC bleeding types 3 or 5
3 months FU
BARC bleeding type 1, 2, 3 or 5
기간: 3 months FU
3 months FU
BARC bleeding type 1, 2, 3 or 5
기간: 12 months FU
12 months FU
Menorrhagia associated quality of life
기간: 3 months FU
assessed with Menorrhagia multi-attribute scale (MMAS), consisting of 6 dimensions with 4-level Likert scale for responses
3 months FU
Menorrhagia associated quality of life
기간: 12 months FU
assessed with Menorrhagia multi-attribute scale (MMAS), consisting of 6 dimensions with 4-level Likert scale for responses
12 months FU
MACE
기간: 3 Months follow-up
composite endpoint consisting of all-cause mortality, myocardial infarction, recurrent SCAD, unplanned coronary revascularization, ischemic stroke, or transient ischemic attack
3 Months follow-up
Health-related Quality of Life
기간: 3 months FU
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)
3 months FU
Health-related Quality of Life
기간: 12 months FU
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)
12 months FU
Patient Health Questionnaire PHQ-8
기간: 3 months FU
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
3 months FU
Patient Health Questionnaire PHQ-8
기간: 12 months FU
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
12 months FU
Generalized Anxiety Disorder (GAD-7) questionnaire
기간: 3 months FU
screening tool to identify probable cases of GAD and to assess symptom severity. 7 items and 4-level Likert-scale
3 months FU
Generalized Anxiety Disorder (GAD-7) questionnaire
기간: 12 months FU
screening tool to identify probable cases of GAD and to assess symptom severity. 7 items and 4-level Likert-scale
12 months FU

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Universitätsklinikum Hamburg-Eppendorf

협력자

Gesellschaft für Therapieforschung mbH
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
National Institute for Health Research Leicester Biomedical Research Centre, Leicester, UK
Cardio-CARE AG, Davos

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2027년 3월 1일

기본 완료 (추정된)

2033년 2월 28일

연구 완료 (추정된)

2033년 2월 28일

연구 등록 날짜

최초 제출

2026년 6월 2일

QC 기준을 충족하는 최초 제출

2026년 6월 28일

처음 게시됨 (실제)

2026년 7월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 28일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • SCAD-ALIGN-DZHK31
  • 2025-523985-26-00 (씨티스)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

to be determined as global study with various stakeholders and country-specific requirements.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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