Switching From Ticagrelor to Prasugrel in Patients With Acute Coronary Syndrome

NCT ID: NCT05183178

Last Updated: 2022-03-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 16000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2025-12-31

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

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ticagrelor

Current standard of care

Group Type: ACTIVE_COMPARATOR

Ticagrelor 90 mg

Intervention Type: DRUG

Ticagrelor 90 mg twice daily p.o.

Prasugrel

New standard of care

Group Type: EXPERIMENTAL

Prasugrel 10 mg p.o

Intervention Type: DRUG

Prasugrel 10 mg once daily p.o. Patient \>75 years of age or \<60 kg will receive 5 mg prasugrel OD.

Interventions

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.

Intervention Type: DRUG

Ticagrelor 90 mg

Ticagrelor 90 mg twice daily p.o.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: collaborator

Region Halland

OTHER

Sponsor Role: collaborator

Region Gävleborg

OTHER

Sponsor Role: collaborator

Region Örebro County

OTHER

Sponsor Role: collaborator

Region Västerbotten

OTHER_GOV

Sponsor Role: collaborator

Jämtland County Council, Sweden

OTHER_GOV

Sponsor Role: collaborator

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elmir Omerovic, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska Universitetssjukhus

Locations

Dep. Cardiology, Skånes universitetssjukhus

Lund, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Elmir Omerovic, MD, PhD

Role: CONTACT

elmir@wlab.gu.se

+46313422950

Björn Redfors, MD, PhD

Role: CONTACT

Bjoern.Redfors@wlab.gu.se

+46313427543

Facility Contacts

David Erlinge, MD, PhD

Role: primary

david.erlinge@med.lu.se

Other Identifiers

SWITCH v 1.0 2020-12-10

Identifier Type: -

Identifier Source: org_study_id