Switching From Ticagrelor to Prasugrel in Patients With Acute Coronary Syndrome (SWITCH)

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: Ticagrelor 90 mg; Drug: Prasugrel 10 mg p.o

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

• Study Type: Interventional
• Enrollment (Actual): 17095
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, 22185
    • Dep. Cardiology, Skånes universitetssjukhus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ticagrelor; Current standard of care	Drug: Ticagrelor 90 mg; Ticagrelor 90 mg twice daily p.o.
Experimental: Prasugrel; New standard of care	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative risk (%)	Cumulative risk of death, myocardial infarction or stroke	1-year

Secondary Outcome Measures

Outcome Measure	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	Within 30 days

Other Outcome Measures

Outcome Measure	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	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; 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
Cumulative all-cause mortality (%)	Cumulative all-cause mortality	2 years and yearly up to 15 years.

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Collaborators: Region Skane; Region Örebro County; Region Västerbotten; Jämtland County Council, Sweden; Region Gävleborg; Region Halland
• Investigators: Principal Investigator: Elmir Omerovic, MD, PhD, Sahlgrenska Universitetssjukhus

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): August 31, 2025
• Study Completion (Actual): August 31, 2025

Study Registration Dates

• First Submitted: November 19, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Acute Coronary Syndrome; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleic Acids, Nucleotides, and Nucleosides; Purines; Nucleosides; Ribonucleosides; Thiophenes; Adenosine; Purine Nucleosides; Piperazines; Ticagrelor; Prasugrel Hydrochloride
• Other Study ID Numbers: SWITCH v 1.0 2020-12-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No