Switching From Ticagrelor to Prasugrel in Patients With Acute Coronary Syndrome

NCT05183178 | Unknown Phase 4

• 1 other identifier: SWITCH v 1.0 2020-12-10
• Study Type: interventional
• Target: 16,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• Cumulative risk (%)

  Cumulative risk of death, myocardial infarction or stroke

  1-year

Secondary Outcomes (2)

• Cost effectiveness ratio (%)

  1-year

• Bleeding or Death ratio (%)

  Within 30 days

Other Outcomes (7)

• Cumulative incidence of death (%)

  1-year

• Cumulative incidence myocardial infarction or death (%)

  1-year

• The composite of all-cause death, myocardial infarction, or stroke (%)

  Within 30 days

Study Arms (2)

Ticagrelor

ACTIVE COMPARATOR

Current standard of care

Drug: Ticagrelor 90 mg

Prasugrel

EXPERIMENTAL

New standard of care

Drug: Prasugrel 10 mg p.o

Interventions

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.

Prasugrel

Ticagrelor 90 mg DRUG

Ticagrelor 90 mg twice daily p.o.

Ticagrelor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients on oral anticoagulation therapy
• Previous stroke

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Region Skane: collaborator
• Region Halland: collaborator
• Region Gävleborg: collaborator
• Region Örebro County: collaborator
• Region Västerbotten: collaborator
• Jämtland County Council, Sweden: collaborator

Study Sites (1)

Dep. Cardiology, Skånes universitetssjukhus

Lund, 22185, Sweden

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Prasugrel Hydrochloride; Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Elmir Omerovic, MD, PhD

  Sahlgrenska Universitetssjukhus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elmir Omerovic, MD, PhD

CONTACT

+46313422950; elmir@wlab.gu.se

Björn Redfors, MD, PhD

CONTACT

+46313427543; Bjoern.Redfors@wlab.gu.se

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Stepped wedge cluster randomized evaluation in the SWEDEHEART-registry

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: January 10, 2022
• Study Start: February 1, 2022
• Primary Completion: January 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 17, 2022

Record last verified: 2021-11

Locations

SE (1)