Acute Coronary Syndrome
Conditions
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
Interventions
DRUGPrasugrel 10 mg p.o
Prasugrel 10 mg once daily p.o. Patient \>75 years of age or \<60 kg will receive 5 mg prasugrel OD.
DRUGTicagrelor 90 mg
Ticagrelor 90 mg twice daily p.o.
Sponsors
Region Skane
Region Halland
Region Gävleborg
Region Örebro County
Region Västerbotten
Jämtland County Council, Sweden
Vastra Gotaland Region
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Stepped wedge cluster randomized evaluation in the SWEDEHEART-registry
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative risk (%) | 1-year | Cumulative risk of death, myocardial infarction or stroke |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost effectiveness ratio (%) | 1-year | Cost effectiveness of Prasugrel compared to Ticagrelor. |
| Bleeding or Death ratio (%) | Within 30 days | Bleeding or death (in-hospital) within30 days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of major bleeding (%) | Within 30 days | Major bleeding |
| The composite of all-cause death, myocardial infarction, stroke or urgent revascularization (%) | Within 30 days | The composite of all-cause death, myocardial infarction, stroke or urgent revascularization (defined as re-intervention due to acute coronary syndrome) |
| Cumulative incidence of death (%) | 1-year | Risk of death |
| Cumulative all-cause mortality (%) | 2 years and yearly up to 15 years. | Cumulative all-cause mortality |
| The cumulative incidence of endpoints (%) | 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 |
| Cumulative incidence myocardial infarction or death (%) | 1-year | Risk of myocardial infarction or death |
| The composite of all-cause death, myocardial infarction, or stroke (%) | Within 30 days | The composite of all-cause death, myocardial infarction, or stroke |
Countries
Sweden
Contacts
Primary ContactElmir Omerovic, MD, PhD
Backup ContactBjörn Redfors, MD, PhD
Outcome results
None listed