Acute Coronary SyndromePhase 4SWITCHNCT05183178
Switching From Ticagrelor to Prasugrel in Patients With Acute Coronary Syndrome
A Phase 4 study testing Prasugrel 10 mg p.o and Ticagrelor 90 mg in people with Acute Coronary Syndrome, run by Vastra Gotaland Region at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Prasugrel 10 mg p.o and Ticagrelor 90 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17,095 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2022to 31 Aug 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
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:
- To investigate the cost effectiveness of Prasugrel compared to Ticagrelor with respect to the 1-year outcomes.
- To investigate clinical safety of Prasugrel compared to Ticagrelor
- Conditions
- Acute Coronary Syndrome
- Being tested
- Prasugrel 10 mg p.o, Ticagrelor 90 mg
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prasugrel 10 mg p.oDrug
Prasugrel 10 mg once daily p.o. Patient >75 years of age or <60 kg will receive 5 mg prasugrel OD.
Ticagrelor 90 mgDrug
Ticagrelor 90 mg twice daily p.o.
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Active comparator | Current standard of care Receives: Drug: Ticagrelor 90 mg |
| Prasugrel | Experimental | New standard of care Receives: Drug: Prasugrel 10 mg p.o |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative risk (%)
Cumulative risk of death, myocardial infarction or stroke
Measured: 1-year
Secondary outcomes (2)
Cost effectiveness ratio (%)
Cost effectiveness of Prasugrel compared to Ticagrelor.
Measured: 1-year
Bleeding or Death ratio (%)
Bleeding or death (in-hospital) within30 days
Measured: Within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start1 Feb 2022
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped wedge cluster randomized evaluation in the SWEDEHEART-registry
- Masking
- None (open label)
- Enrolment
- 17,095 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Region Skane, Region Halland, Region Gävleborg, Region Örebro County, Region Västerbotten, Jämtland County Council, Sweden
- Responsible party
- Sponsor
- Investigators
- Elmir Omerovic, MD, PhD, Principal investigator, Sahlgrenska Universitetssjukhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183178
- Sponsor's protocol ID
- SWITCH v 1.0 2020-12-10
- Acronym
- SWITCH
- Status last verified
- Apr 2026
- First submitted
- 19 Nov 2021
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Omerovic E, Koul S, Andersson J, Ponten J, Bjorklund F, Kastberg R, Sun M, Ljungman C, Frobert O, Bolin K, Skoglund K, Dolata CD, Birgander M, Wikstrom H, Ramunddal T, Angeras O, Petursson P, Erlinge D, Redfors B. Prasugrel versus Ticagrelor in Acute Coronary Syndromes. N Engl J Med. 2026 Aug 29. doi: 10.1056/NEJMoa2609057. Online ahead of print.
PubMed 42670968
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switching From Ticagrelor to Prasugrel in Patients With Acute Coronary Syndrome-a Stepped Wedge Cluster Randomized Evaluation in the SWEDEHEART-registry
- ClinicalTrials.gov ID
- NCT05183178
- Acronym / sponsor ID
- SWITCH / SWITCH v 1.0 2020-12-10
- Conditions
- Acute Coronary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17,095 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Region Skane, Region Halland, Region Gävleborg, Region Örebro County, Region Västerbotten, Jämtland County Council, Sweden
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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:
- To investigate the cost effectiveness of Prasugrel compared to Ticagrelor with respect to the 1-year outcomes.
- To investigate clinical safety of Prasugrel compared to Ticagrelor
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped wedge cluster randomized evaluation in the SWEDEHEART-registry
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Active comparator | Drug: Ticagrelor 90 mgCurrent standard of care |
| Prasugrel | Experimental | Drug: Prasugrel 10 mg p.oNew standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prasugrel 10 mg p.oPrasugrel 10 mg once daily p.o. Patient >75 years of age or <60 kg will receive 5 mg prasugrel OD. | Drug | Prasugrel |
| Ticagrelor 90 mgTicagrelor 90 mg twice daily p.o. | Drug | Ticagrelor |
Primary outcome
Cumulative risk (%)
Time frame: 1-year
Cumulative risk of death, myocardial infarction or stroke
2 secondary outcomes
Cost effectiveness ratio (%)
Time frame: 1-year
Bleeding or Death ratio (%)
Time frame: Within 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Derived from this study: PubMed 42670968Omerovic E, Koul S, Andersson J, Ponten J, Bjorklund F, Kastberg R, Sun M, Ljungman C, Frobert O, Bolin K, Skoglund K, Dolata CD, Birgander M, Wikstrom H, Ramunddal T, Angeras O, Petursson P, Erlinge D, Redfors B. Prasugrel versus Ticagrelor in Acute Coronary Syndromes. N Engl J Med. 2026 Aug 29. doi: 10.1056/NEJMoa2609057. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elmir Omerovic, MD, PhD principal investigator
Sahlgrenska Universitetssjukhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prasugrel 10 mg p.o and Ticagrelor 90 mg in people with Acute Coronary Syndrome, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative risk (%) (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05183178, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.