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

2026年6月28日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

3518

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • イギリス
      • Leicester、イギリス、LE1 5WW
        • University Hospitals of Leicester NHS Trust
        • コンタクト：
  • オランダ
      • Nieuwegein、オランダ、3435 CM
        • Division of Cardiology, St. Antonius Hospital
        • コンタクト：
  • カナダ
    • British Columbia
      • Vancouver、British Columbia、カナダ、V5Z 1M9
        • Division of Cardiology, Vancouver General Hospital, University of British Columbia
        • コンタクト：
  • スウェーデン
      • Linköping、スウェーデン、SE-581 83
        • Department of Cardiology and Department of Medical and Health Sciences, Linköping University
        • コンタクト：
  • ドイツ
    • Free and Hanseatic City of Hamburg
      • Hamburg、Free and Hanseatic City of Hamburg、ドイツ、20246
        • University Medical Center Hamburg-Eppendorf
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：moderate APT
moderate APT therapy, defined as 3 months ASA followed by cessation of APT
薬：Acetylsalicylic acid ASA
3 months ASA monotherapy, dose accoring to international guidelines and local Standard of Care
アクティブコンパレータ：intensive APT
intensive APT therapy, defined as 3 months DAPT (ASA + clopidogrel), followed by 9 months of clopidogrel monotherapy
薬：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

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
MACE (Major Adverse Cardiovascular Events) with all-cause-mortality
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
First secondary endpoint: MACE (Major Adverse Cardiovascular Events) with cardiovascular mortality
時間枠：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)
時間枠：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
時間枠：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
時間枠：3 months FU
3 months FU
all-cause mortality
時間枠：12 months FU
12 months FU
cardiovascular mortality
時間枠：3 months FU
3 months FU
cardiovascular mortality
時間枠：12 months FU
12 months FU
myocardial infarction
時間枠：3 months FU
3 months FU
myocardial infarction
時間枠：12 months FU
12 months FU
recurrent SCAD
時間枠：3 months FU
3 months FU
recurrent SCAD
時間枠：12 months FU
12 months FU
unplanned coronary revascularization
時間枠：3 months FU
3 months FU
unplanned coronary revascularization
時間枠：12 months FU
12 months FU
ischemic stroke
時間枠：3 months FU
3 months FU
ischemic stroke
時間枠：12 months FU
12 months FU
transient ischemic attack
時間枠：3 months FU
3 months FU
transient ischemic attack
時間枠：12 months FU
12 months FU
NACE
時間枠：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
時間枠：3 months FU
3 months FU
BARC bleeding type 1, 2, 3 or 5
時間枠：12 months FU
12 months FU
Menorrhagia associated quality of life
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Universitätsklinikum Hamburg-Eppendorf

協力者

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

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2027年3月1日

一次修了 (推定)

2033年2月28日

研究の完了 (推定)

2033年2月28日

試験登録日

最初に提出

2026年6月2日

QC基準を満たした最初の提出物

2026年6月28日

最初の投稿 (実際)

2026年7月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月6日

QC基準を満たした最後の更新が送信されました

2026年6月28日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

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

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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