Switching From Ticagrelor to Prasugrel in Patients With Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— SWITCH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05183178
• Other study ID #: SWITCH v 1.0 2020-12-10
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2021
• Source: Vastra Gotaland Region
• Contact: Elmir Omerovic, MD, PhD
• Phone: +46313422950
• Email: elmir[@]wlab.gu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16000
• Est. completion date: December 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Prasugrel 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.
• Ticagrelor 90 mg
Ticagrelor 90 mg twice daily p.o.

Locations

Country	Name	City	State
Sweden	Dep. Cardiology, Skånes universitetssjukhus	Lund

Sponsors (7)

Lead Sponsor	Collaborator
Vastra Gotaland Region	Jämtland County Council, Sweden, Region Gävleborg, Region Halland, Region Örebro County, Region Skane, Region Västerbotten

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cumulative incidence of death (%)	Risk of death	1-year
Other	Cumulative incidence myocardial infarction or death (%)	Risk of myocardial infarction or death	1-year
Other	The composite of all-cause death, myocardial infarction, or stroke (%)	The composite of all-cause death, myocardial infarction, or stroke	Within 30 days
Other	Cumulative incidence of major bleeding (%)	Major bleeding	Within 30 days
Other	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
Other	The cumulative incidence of endpoints (%)	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	Within 30 days and 1 year
Other	Cumulative all-cause mortality (%)	Cumulative all-cause mortality	2 years and yearly up to 15 years.
Primary	Cumulative risk (%)	Cumulative risk of death, myocardial infarction or stroke	1-year
Secondary	Cost effectiveness ratio (%)	Cost effectiveness of Prasugrel compared to Ticagrelor.	1-year
Secondary	Bleeding or Death ratio (%)	Bleeding or death (in-hospital) within30 days	Within 30 days