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| Name | Class |
|---|---|
| Region Skane | OTHER |
| Region Halland | OTHER |
| Region Gävleborg | OTHER |
| Region Örebro County |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor | Active Comparator | Current standard of care |
|
| Prasugrel | Experimental | New standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative risk (%) | Cumulative risk of death, myocardial infarction or stroke | 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| Cost effectiveness ratio (%) | Cost effectiveness of Prasugrel compared to Ticagrelor. | 1-year |
| Bleeding or Death ratio (%) | Bleeding or death (in-hospital) within30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of death (%) | Risk of death | 1-year |
| Cumulative incidence myocardial infarction or death (%) | Risk of myocardial infarction or death |
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elmir Omerovic, MD, PhD | Sahlgrenska Universitetssjukhus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. Cardiology, Skånes universitetssjukhus | Lund | 22185 | Sweden |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068799 | Prasugrel Hydrochloride |
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
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| Region Västerbotten | OTHER_GOV |
| Jämtland County Council, Sweden | OTHER_GOV |
Stepped wedge cluster randomized evaluation in the SWEDEHEART-registry
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| Ticagrelor 90 mg | Drug | Ticagrelor 90 mg twice daily p.o. |
|
| Within 30 days |
| 1-year |
| The composite of all-cause death, myocardial infarction, or stroke (%) | The composite of all-cause death, myocardial infarction, or stroke | Within 30 days |
| Cumulative incidence of major bleeding (%) | Major bleeding | Within 30 days |
| The composite of all-cause death, myocardial infarction, stroke or urgent revascularization (%) | The composite of all-cause death, myocardial infarction, stroke or urgent revascularization (defined as re-intervention due to acute coronary syndrome) | Within 30 days |
| The cumulative incidence of endpoints (%) | The cumulative incidence of the following endpoints;
| Within 30 days and 1 year |
| Cumulative all-cause mortality (%) | Cumulative all-cause mortality | 2 years and yearly up to 15 years. |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |