Clinical trial NCT05183178: Switching From Ticagrelor to Prasugrel in Patients With Acute Coronary Syndrome
Official title: Switching From Ticagrelor to Prasugrel in Patients With Acute Coronary Syndrome-a Stepped Wedge Cluster Randomized Evaluation in the SWEDEHEART-registry
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Region Skane
name: Region Halland
name: Region Gävleborg
name: Region Örebro County
name: Region Västerbotten
name: Jämtland County Council, Sweden
First posted: 2022-01-10
Enrollment: 16000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped wedge cluster randomized evaluation in the SWEDEHEART-registry
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Primary objective:

• To investigate the clinical efficacy of Prasugrel compared to Ticagrelor for the treatment of patients hospitalized for acute coronary syndrome

Secondary objectives:

* To investigate the cost effectiveness of Prasugrel compared to Ticagrelor for the treatment of patients hospitalized for acute coronary syndrome (ICD-10 codes: I21-I22), with respect to the 1-year outcomes.
* To investigate clinical safety of Prasugrel compared to Ticagrelor for the treatment of patients hospitalized for acute coronary syndrome

Eligibility criteria: 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.

Exclusion Criteria:

* Patients on oral anticoagulation therapy
* Previous stroke

Primary outcomes:
measure: Cumulative risk (%)
timeFrame: 1-year
Secondary outcomes:
measure: Cost effectiveness ratio (%)
timeFrame: 1-year
measure: Bleeding or Death ratio (%)
timeFrame: Within 30 days
Other outcomes:
measure: Cumulative incidence of death (%)
timeFrame: 1-year
measure: Cumulative incidence myocardial infarction or death (%)
timeFrame: 1-year
measure: The composite of all-cause death, myocardial infarction, or stroke (%)
timeFrame: Within 30 days
measure: Cumulative incidence of major bleeding (%)
timeFrame: Within 30 days
measure: The composite of all-cause death, myocardial infarction, stroke or urgent revascularization (%)
timeFrame: Within 30 days
measure: The cumulative incidence of endpoints (%)
timeFrame: Within 30 days and 1 year
measure: Cumulative all-cause mortality (%)
timeFrame: 2 years and yearly up to 15 years.
Locations:
city: Lund
country: Sweden
facility: Dep. Cardiology, Skånes universitetssjukhus
Study officials:
affiliation: Sahlgrenska Universitetssjukhus
name: Elmir Omerovic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: