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

28 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

3518

Faza

  • Faza 4

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Holandia
      • Nieuwegein, Holandia, 3435 CM
        • Division of Cardiology, St. Antonius Hospital
        • Kontakt:
  • Kanada
    • British Columbia
      • Vancouver, British Columbia, Kanada, V5Z 1M9
        • Division of Cardiology, Vancouver General Hospital, University of British Columbia
        • Kontakt:
  • Niemcy
    • Free and Hanseatic City of Hamburg
      • Hamburg, Free and Hanseatic City of Hamburg, Niemcy, 20246
        • University Medical Center Hamburg-Eppendorf
        • Kontakt:
  • Szwecja
      • Linköping, Szwecja, SE-581 83
        • Department of Cardiology and Department of Medical and Health Sciences, Linköping University
        • Kontakt:
  • Zjednoczone Królestwo
      • Leicester, Zjednoczone Królestwo, LE1 5WW
        • University Hospitals of Leicester NHS Trust
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: moderate APT
moderate APT therapy, defined as 3 months ASA followed by cessation of APT
Lek: Acetylsalicylic acid ASA
3 months ASA monotherapy, dose accoring to international guidelines and local Standard of Care
Aktywny komparator: intensive APT
intensive APT therapy, defined as 3 months DAPT (ASA + clopidogrel), followed by 9 months of clopidogrel monotherapy
Lek: 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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
MACE (Major Adverse Cardiovascular Events) with all-cause-mortality
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
First secondary endpoint: MACE (Major Adverse Cardiovascular Events) with cardiovascular mortality
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 3 months FU
3 months FU
all-cause mortality
Ramy czasowe: 12 months FU
12 months FU
cardiovascular mortality
Ramy czasowe: 3 months FU
3 months FU
cardiovascular mortality
Ramy czasowe: 12 months FU
12 months FU
myocardial infarction
Ramy czasowe: 3 months FU
3 months FU
myocardial infarction
Ramy czasowe: 12 months FU
12 months FU
recurrent SCAD
Ramy czasowe: 3 months FU
3 months FU
recurrent SCAD
Ramy czasowe: 12 months FU
12 months FU
unplanned coronary revascularization
Ramy czasowe: 3 months FU
3 months FU
unplanned coronary revascularization
Ramy czasowe: 12 months FU
12 months FU
ischemic stroke
Ramy czasowe: 3 months FU
3 months FU
ischemic stroke
Ramy czasowe: 12 months FU
12 months FU
transient ischemic attack
Ramy czasowe: 3 months FU
3 months FU
transient ischemic attack
Ramy czasowe: 12 months FU
12 months FU
NACE
Ramy czasowe: 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
Ramy czasowe: 3 months FU
3 months FU
BARC bleeding type 1, 2, 3 or 5
Ramy czasowe: 12 months FU
12 months FU
Menorrhagia associated quality of life
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Współpracownicy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 marca 2027

Zakończenie podstawowe (Szacowany)

28 lutego 2033

Ukończenie studiów (Szacowany)

28 lutego 2033

Daty rejestracji na studia

Pierwszy przesłany

2 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

28 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

6 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

28 czerwca 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

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

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Opis planu IPD

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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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