ST Elevation Myocardial InfarctionSTOP-IMHNCT05986968
Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage
A study testing Ticagrelor and Aspirin in people with ST Elevation Myocardial Infarction, run by Radboud University Medical Center at 5 sites in Netherlands.
Trial summary
The main goal of this clinical trial is to assess whether direct omission of aspirin after Percutaneous Coronary Intervention (PCI) with the continuation of ticagrelor monotherapy for 12 months versus 12 months ticagrelor plus aspirin is equally safe regarding the incidence of ischemic events in patients with ST… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- Ticagrelor and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesNetherlands
- Study dates
- 6 Jul 2023to 12 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Clinical and electrocardiographical diagnosis of STEMI
- Successful PCI (according to the treating physician) of the infarct-related vessel with a modern drug-eluting stent (DES)
Who cannot join
- Known allergy or contraindication for aspirin, ticagrelor or prasugrel.
- Previous PCI or MI less than 12 months ago
- Previous cardiac surgery
- Participation in another clinical cardiology study or study concerning platelet aggregation/ thrombosis. (unless the antithrombotic therapy prescribed in this other study will end due to clinical reasons (e.g. the STEMI))
- Pregnancy and breast feeding
- Concurrent use of oral anticoagulants (OAC)
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- The periprocedural use of GPIIb/IIIa inhibitors
- Planned surgical intervention within 12 months of PCI
- Creatinine clearance <30mL/min or dialysis
- PCI of stent thrombosis
- Suboptimal stent result as judged by the interventional cardiologist.
- Life expectancy shorter than 13 months.
- Contra-indications for MRI or unable to undergo MRI (only applicable for the CMR subgroup population).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites
Noordwest Ziekenhuisgroep Alkmaar
Alkmaar
Amsterdam UMC
Amsterdam
Rijnstate
Arnhem
Medisch Spectrum Twente
Enschede
Radboudumc
Nijmegen
About this study
The main goal of this clinical trial is to assess whether direct omission of aspirin after Percutaneous Coronary Intervention (PCI) with the continuation of ticagrelor monotherapy for 12 months versus 12 months ticagrelor plus aspirin is equally safe regarding the incidence of ischemic events in patients with ST elevation myocardial infarction (STEMI). Furthermore, the two treatment strategies will be compared regarding the incidence and extent of intramyocardial haemorrhage (IMH) and infarct size in the first week after PCI as determined with Cardiac Magnetic Resonance (CMR). The secondary efficacy endpoint consists of clinical bleeding events and all-cause mortality. The main analyses will comprise of clinical outcomes in the first three months after primary PCI and of CMR results. In addition, we will report on clinical outcomes at thirteen months.
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- Ticagrelor, Aspirin
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Ticagrelor monotherapy for 12 months
AspirinDrug
Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Ticagrelor monotherapy instead of dual antiplatelet therapy (aspirin plus ticagrelor) Receives: Drug: Ticagrelor |
| Control arm | Active comparator | Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months. Receives: Drug: Ticagrelor; Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of major adverse cardiac and cerebral events (MACCE)
Consisting of: myocardial infarction, stent thrombosis, ischemic stroke, cardiovascular mortality / all-cause mortality
Measured: 3 and 13 months after primary PCI
Intramyocardial haemorrhage (IMH)
Size of IMH and infarct determined by Cardiac Magnetic Resonance imaging at day 5-8 post primary PCI.
Measured: day 5-8 post primary PCI
Secondary outcomes (3)
Bleeding complications
Defined as Bleeding Academic Research Consortium (BARC) 2 or greater
Measured: 3 and 13 months after primary PCI
All-cause mortality
Measured: 3 and 13 months after primary PCI
Platelet reactivity
Differences in platelet reactivity between ticagrelor monotherapy and ticagrelor + aspirin will be measured as Aspirin Reaction Units (ARU) using the VerifyNow test.
Measured: 5-8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start6 Jul 2023
- Primary completion3 Jan 2026
- Study completion12 Dec 2026 (estimated)
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 ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986968
- Sponsor's protocol ID
- NL82646.091.22
- Acronym
- STOP-IMH
- Status last verified
- Aug 2026
- First submitted
- 10 Jul 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yosofi B, Woelders ECI, Peeters DAM, von Birgelen C, van Rees JB, Heestermans AACM, Claessen BEPM, van den Oord SCH, Dirksen MT, van Vliet D, Konijnenberg LSF, Cetinyurek-Yavuz A, van Royen N, van Geuns RM, Nijveldt R, Damman P. Ticagrelor monotherapy versus dual antiplatelet therapy after primary percutaneous coronary intervention: one-year outcomes of the pilot STOP-IMH randomised trial. EuroIntervention. 2026 Jul 20;22(14):e773-e783. doi: 10.4244/EIJ-D-26-00421.
PubMed 42200636
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage
- ClinicalTrials.gov ID
- NCT05986968
- Acronym / sponsor ID
- STOP-IMH / NL82646.091.22
- Conditions
- ST Elevation Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 3 Jan 2026 (actual)
- Study completion
- 12 Dec 2026 (estimated)
- First posted
- 14 Aug 2023 (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.
The main goal of this clinical trial is to assess whether direct omission of aspirin after Percutaneous Coronary Intervention (PCI) with the continuation of ticagrelor monotherapy for 12 months versus 12 months ticagrelor plus aspirin is equally safe regarding the incidence of ischemic events in patients with ST elevation myocardial infarction (STEMI). Furthermore, the two treatment strategies will be compared regarding the incidence and extent of intramyocardial haemorrhage (IMH) and infarct size in the first week after PCI as determined with Cardiac Magnetic Resonance (CMR). The secondary efficacy endpoint consists of clinical bleeding events and all-cause mortality. The main analyses will comprise of clinical outcomes in the first three months after primary PCI and of CMR results. In addition, we will report on clinical outcomes at thirteen months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: TicagrelorTicagrelor monotherapy instead of dual antiplatelet therapy (aspirin plus ticagrelor) |
| Control arm | Active comparator | Drug: Ticagrelor, Drug: AspirinDual antiplatelet therapy (aspirin plus ticagrelor) for 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical and electrocardiographical diagnosis of STEMI
- Successful PCI (according to the treating physician) of the infarct-related vessel with a modern drug-eluting stent (DES)
Key exclusion criteria (13 listed)
- Known allergy or contraindication for aspirin, ticagrelor or prasugrel.
- Previous PCI or MI less than 12 months ago
- Previous cardiac surgery
- Participation in another clinical cardiology study or study concerning platelet aggregation/ thrombosis. (unless the antithrombotic therapy prescribed in this other study will end due to clinical reasons (e.g. the STEMI))
- Pregnancy and breast feeding
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 |
|---|---|---|
| TicagrelorTicagrelor monotherapy for 12 months | Drug | Control arm, Treatment arm |
| AspirinDual antiplatelet therapy (aspirin plus ticagrelor) for 12 months | Drug | Control arm |
Primary outcome
Composite of major adverse cardiac and cerebral events (MACCE)
Time frame: 3 and 13 months after primary PCI
Consisting of: myocardial infarction, stent thrombosis, ischemic stroke, cardiovascular mortality / all-cause mortality
Intramyocardial haemorrhage (IMH)
Time frame: day 5-8 post primary PCI
Size of IMH and infarct determined by Cardiac Magnetic Resonance imaging at day 5-8 post primary PCI.
3 secondary outcomes
Bleeding complications
Time frame: 3 and 13 months after primary PCI
All-cause mortality
Time frame: 3 and 13 months after primary PCI
Platelet reactivity
Time frame: 5-8 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Derived from this study: PubMed 42200636Yosofi B, Woelders ECI, Peeters DAM, von Birgelen C, van Rees JB, Heestermans AACM, Claessen BEPM, van den Oord SCH, Dirksen MT, van Vliet D, Konijnenberg LSF, Cetinyurek-Yavuz A, van Royen N, van Geuns RM, Nijveldt R, Damman P. Ticagrelor monotherapy versus dual antiplatelet therapy after primary percutaneous coronary intervention: one-year outcomes of the pilot STOP-IMH randomised trial. EuroIntervention. 2026 Jul 20;22(14):e773-e783. doi: 10.4244/EIJ-D-26-00421.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ticagrelor and Aspirin in people with ST Elevation Myocardial Infarction, run by Radboud University Medical Center at 5 sites in Netherlands.
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 13 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: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Composite of major adverse cardiac and cerebral events (MACCE) (time frame: 3 and 13 months after primary PCI). The study lists 2 primary outcomes in all. 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 NCT05986968, 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 14 Aug 2026.