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Completed

NCT Number: NCT05183178

Switching From Ticagrelor to Prasugrel in Patients With Acute Coronary Syndrome

This study proposes to conduct the switch from ticagrelor to prasugrel in an organized stepwise manner, to allow for the evaluation of the relative efficacy of prasugrel versus ticagrelor using a stepped-wedge cluster randomized trial design.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dep. Cardiology, Skånes universitetssjukhus

Lund, 22185, Sweden

About this study

The SWITCH SWEDEHEART trial is a prospective, multicenter, open-label, cross-sectional, stepped wedge cluster randomized clinical study, in which administrative regions in Sweden will constitute the clusters. Many administrative regions have already decided to switch from ticagrelor to prasugrel for the treatment of patients with ACS. The order in which the regions make the switch will be randomly assigned. At the start of the study, all regions will utilize and prescribe ticagrelor as the P2Y12 inhibitor drug of choice for patients with ACS. After 9 months, one cluster will switch from ticagrelor to prasugrel as the P2Y12 inhibitor of choice for patients with ACS. Every 9 months, an additional cluster will switch to prasugrel until all clusters have switched from ticagrelor to prasugrel. Study enrollment will be stop 9 months after the last cluster has switched to prasugrel. The study will be terminated when 1-year follow-up has been concluded for all patients.

All patients who are hospitalized due to acute coronary syndrome in any of the health care regions over the course of the study period will be included. All patients will be treated according to local treatment guidelines at the time of the index hospitalization (prasugrel or ticagrelor) for at least 12 months. Patients with relative or absolute contra-indications for the study drugs or patients experiencing side effects requiring treatment changes will be treated according to current guidelines at the discretion of the treating physician.

The patients will be identified via the Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART) registry. The events at 1 year will be identified and extracted from Patient registry (Socialstyrelsen), Population registry (Folkbokföringen), Causes of death registry (Socialstyrelsen). Compliance with the treatment after the transition from ticagrelor to prasugrel will be followed through Dispensed drug registry (Socialstyrelsen).

The primary analysis population will be patients undergoing percutaneous coronary intervention (PCI) due to ACS. The secondary analysis population will be all patients hospitalized with ACS.

Primary objective:

  • To investigate the clinical efficacy of Prasugrel compared to Ticagrelor

Secondary objectives:

  • To investigate the cost effectiveness of Prasugrel compared to Ticagrelor with respect to the 1-year outcomes.
  • To investigate clinical safety of Prasugrel compared to Ticagrelor

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients hospitalized for Acute coronary syndrome, as defined by the European Society of Cardiology, at any hospital participating in the study, and included in the SWEDEHEART registry during index hospitalization
  • Age ≥ 18 years.

Treatment and study plan

Prasugrel 10 mg p.o

Drug

Prasugrel 10 mg once daily p.o. Patient >75 years of age or <60 kg will receive 5 mg prasugrel OD.

Ticagrelor 90 MG

Drug

Ticagrelor 90 mg twice daily p.o.

Primary outcomes

  1. Cumulative risk (%)

    Time frame: 1-year

    Cumulative risk of death, myocardial infarction or stroke

Secondary outcomes

  1. Cost effectiveness ratio (%)

    Time frame: 1-year

    Cost effectiveness of Prasugrel compared to Ticagrelor.

  2. Bleeding or Death ratio (%)

    Time frame: Within 30 days

    Bleeding or death (in-hospital) within30 days

Other outcomes

  1. Cumulative incidence of death (%)

    Time frame: 1-year

    Risk of death

  2. Cumulative incidence myocardial infarction or death (%)

    Time frame: 1-year

    Risk of myocardial infarction or death

  3. The composite of all-cause death, myocardial infarction, or stroke (%)

    Time frame: Within 30 days

    The composite of all-cause death, myocardial infarction, or stroke

  4. Cumulative incidence of major bleeding (%)

    Time frame: Within 30 days

    Major bleeding

  5. The composite of all-cause death, myocardial infarction, stroke or urgent revascularization (%)

    Time frame: Within 30 days

    The composite of all-cause death, myocardial infarction, stroke or urgent revascularization (defined as re-intervention due to acute coronary syndrome)

  6. The cumulative incidence of endpoints (%)

    Time frame: Within 30 days and 1 year

    The cumulative incidence of the following endpoints;

    • All-cause mortality
    • Definite or probable stent thrombosis
    • Definite stent thrombosis
    • Myocardial infarction
    • Stroke
    • Major bleeding
    • Ischemia-driven target vessel revascularization
    • Ischemia-driven revascularization
    • Interruption of study drug within 1 year
    • Interruption of dual antiplatelet therapy within 1 year

  7. Cumulative all-cause mortality (%)

    Time frame: 2 years and yearly up to 15 years.

    Cumulative all-cause mortality

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Collaborators

  • Jämtland County Council, Sweden
  • Region Gävleborg
  • Region Halland
  • Region Skane
  • Region Västerbotten
  • Region Örebro County

Registry information

Official study title

Switching From Ticagrelor to Prasugrel in Patients With Acute Coronary Syndrome-a Stepped Wedge Cluster Randomized Evaluation in the SWEDEHEART-registry

Acronym: SWITCH

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 10, 2022
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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