Acute Myocardial InfarctionPhase 2TIMONCT05149560
Ticagrelor Monotherapy After Stenting
A Phase 2 study testing Ticagrelor 90mg in people with Acute Myocardial Infarction, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
A pilot study planned to evaluate initial safety of ticagrelor monotherapy after coronary stenting due to acute myocardial infarction. The study is a single-centre, single-arm, prospective phase II study 200 patients who undergo coronary artery stenting due to NSTEMI or STEMI will be included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Ticagrelor 90mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 14 Dec 2021to 26 Jun 2025
- Phase
- Phase 2
- 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
- Men or women at least 18 years old.
- Pre- or intra-procedure treatment with ticagrelor.
- Coronary stenting with an everolimus-eluting stent (EES) due to NSTEMI or STEMI, with post-procedure diameter stenosis <50% and post-procedure Thrombolysis In Myocardial Infarcton (TIMI) flow grade 3.
- PCI guided by optical coherence tomography (OCT) with MLDMAX workflow
- Subject has not yet received any post-procedure dose of aspirin or any post-procedure dose of a different P2Y12 inhibitor than ticagrelor (loading dose or pre-PCI maintenance dose of aspirin and/or a different P2Y12 inhibitor is allowed)
- Subject has signed and dated the informed consent form.
Who cannot join
- Planned PCI or any planned surgical intervention within the next 6 months.
- Any indication for chronic anticoagulant therapy
- Positive COVID-19 antigen or PCR test regardless of symptoms
- History of definite stent thrombosis
- Left main coronary artery stenting.
- Stent thrombosis/restenosis as a culprit lesion.
Show all 19Show fewer
- Visible thrombus on angiography after PCI
- Usage of glycoprotein IIb/IIIa inhibitors
- Any bifurcation lesion with stenting of both branches.
- Any treated lesion within an arterial or venous graft.
- Any additional lesion(s) that need(s) a staged revascularization.
- Known ejection fraction <30%.
- Known severe renal insufficiency (eGFR <30 ml/min/1.72 m2).
- Any life-threatening conditions or medical comorbidity resulting in life expectancy < 12 months.
- Participation in any investigational study that has not yet reached its primary endpoint, and for which monotherapy with ticagrelor may affect the primary outcome (as per the judgement of the investigator).
- Patients who medicate with a potent CYP3A4 inhibitor (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir)
- Pregnancy or woman of childbearing potential who is not sterilized or using a medically accepted form of contraception.
- Expected inability (by the investigator) to comply with the protocol
- Subjects incapable to giving consent personally
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ticagrelor Monotherapy After Coronary Stenting in Patients With Acute Myocardial Infarction - A Prospective Single-centre, Single-arm Phase II Study
A pilot study planned to evaluate initial safety of ticagrelor monotherapy after coronary stenting due to acute myocardial infarction.
The study is a single-centre, single-arm, prospective phase II study 200 patients who undergo coronary artery stenting due to NSTEMI or STEMI will be included.
Primary endpoint (variable):
The composite of cardiac death, spontaneous myocardial infarction or definite or probable stent thrombosis within 3 months.
Read the detailed description
A pilot study with 200 subjects undergoing coronary stenting due to NSTEMI or STEMI.
All patients will undergo invasive coronary angiography and clinically indicated Percutaneous Coronary Intervention (PCI). PCI will be performed using EES and OCT guidance using the MLDMAX algorithm (Morphology, Length, Diameter, Medial dissection, Apposition, Xpansion). Eligibility criteria will be assessed after completion of PCI.
Patients will be given a drug diary to document and as a reminder of the twice daily ticagrelor administration.
The Data Safety Monitoring Board (DSMB) will continuously review the outcomes for these patients. After the first 50 patients have been recruited and at least 30 of these patients have reached 3-month follow-up or had the primary outcome, the DSMB will convene to decide whether it is safe to proceed with the study. However, the DSMB will strongly consider early termination of the trial if more than 10 primary endpoint events occur.
Patients may be treated with aspirin prior to coronary angiography, as per local treatment guidelines. All patients will be followed for 1 year. After one year, all patients will be treated per the discretion of the treating physician.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Ticagrelor 90mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor 90mgDrug
All patients will be prescribed ticagrelor as monotherapy
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Experimental | Ticagrelor 90 mg twice daily for 12 months Receives: Drug: Ticagrelor 90mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac event
The composite of cardiac death, spontaneous myocardial infarction or definite or probable stent thrombosis.
Measured: within 3 months
Secondary outcomes (7)
Number of Participants with bleeding
Bleeding Academic Research Consortium (BARC) types 3 or 5 bleeding (time-to-event)
Measured: within 12 months
Number of Participants with stent thrombosis or target vessel myocardial infarction
Definite or probable stent thrombosis or spontaneous target vessel myocardial infarction (time-to-event)
Measured: within 12 months
Number of Participants with myocardial infarction
Any spontaneous myocardial infarction (time-to-event)
Measured: within 12 months
Number of Participants that died
All-cause mortality (time-to-event)
Measured: within 12 months
Number of Participants with major adverse cardiac event
The composite of cardiac death, spontaneous target vessel myocardial infarction or definite or probable stent thrombosis
Measured: within 12 months.
Platelet reactivity
Platelet reactivity as assessed by the ADP-test (multiplate).
Measured: at 24 hours
Platelet reactivity
Platelet reactivity as assessed by the ADP-test (multiplate)
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start14 Dec 2021
- Primary completion26 Jun 2025
- Study completion26 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-centre, single-arm, prospective phase II study
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Sahlgrenska University Hospital
- Responsible party
- Sponsor
- Investigators
- Oskar Angerås, MD, PhD, Principal investigator, Sahlgrenska Universitetssjukhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149560
- Sponsor's protocol ID
- EudraCT number: 2021-000823-11
- Acronym
- TIMO
- Status last verified
- Jun 2025
- First submitted
- 24 Nov 2021
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ticagrelor Monotherapy After Coronary Stenting in Patients With Acute Myocardial Infarction - A Prospective Single-centre, Single-arm Phase II Study
- ClinicalTrials.gov ID
- NCT05149560
- Acronym / sponsor ID
- TIMO / EudraCT number: 2021-000823-11
- Conditions
- Acute Myocardial Infarction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Sahlgrenska University Hospital
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 8 Dec 2021 (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.
A pilot study planned to evaluate initial safety of ticagrelor monotherapy after coronary stenting due to acute myocardial infarction.
The study is a single-centre, single-arm, prospective phase II study 200 patients who undergo coronary artery stenting due to NSTEMI or STEMI will be included.
Primary endpoint (variable):
The composite of cardiac death, spontaneous myocardial infarction or definite or probable stent thrombosis within 3 months.
Detailed description
A pilot study with 200 subjects undergoing coronary stenting due to NSTEMI or STEMI.
All patients will undergo invasive coronary angiography and clinically indicated Percutaneous Coronary Intervention (PCI). PCI will be performed using EES and OCT guidance using the MLDMAX algorithm (Morphology, Length, Diameter, Medial dissection, Apposition, Xpansion). Eligibility criteria will be assessed after completion of PCI.
Patients will be given a drug diary to document and as a reminder of the twice daily ticagrelor administration.
The Data Safety Monitoring Board (DSMB) will continuously review the outcomes for these patients. After the first 50 patients have been recruited and at least 30 of these patients have reached 3-month follow-up or had the primary outcome, the DSMB will convene to decide whether it is safe to proceed with the study. However, the DSMB will strongly consider early termination of the trial if more than 10 primary endpoint events occur.
Patients may be treated with aspirin prior to coronary angiography, as per local treatment guidelines. All patients will be followed for 1 year. After one year, all patients will be treated per the discretion of the treating physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-centre, single-arm, prospective phase II study
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Experimental | Drug: Ticagrelor 90mgTicagrelor 90 mg twice daily 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 (6 listed)
- Men or women at least 18 years old.
- Pre- or intra-procedure treatment with ticagrelor.
- Coronary stenting with an everolimus-eluting stent (EES) due to NSTEMI or STEMI, with post-procedure diameter stenosis <50% and post-procedure Thrombolysis In Myocardial Infarcton (TIMI) flow grade 3.
- PCI guided by optical coherence tomography (OCT) with MLDMAX workflow
- Subject has not yet received any post-procedure dose of aspirin or any post-procedure dose of a different P2Y12 inhibitor than ticagrelor (loading dose or pre-PCI maintenance dose of aspirin and/or a different P2Y12 inhibitor is allowed)
Key exclusion criteria (19 listed)
- Planned PCI or any planned surgical intervention within the next 6 months.
- Any indication for chronic anticoagulant therapy
- Positive COVID-19 antigen or PCR test regardless of symptoms
- History of definite stent thrombosis
- Left main coronary artery stenting.
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 |
|---|---|---|
| Ticagrelor 90mgAll patients will be prescribed ticagrelor as monotherapy | Drug | Ticagrelor |
Primary outcome
Major adverse cardiac event
Time frame: within 3 months
The composite of cardiac death, spontaneous myocardial infarction or definite or probable stent thrombosis.
7 secondary outcomes
Number of Participants with bleeding
Time frame: within 12 months
Number of Participants with stent thrombosis or target vessel myocardial infarction
Time frame: within 12 months
Number of Participants with myocardial infarction
Time frame: within 12 months
Number of Participants that died
Time frame: within 12 months
Number of Participants with major adverse cardiac event
Time frame: within 12 months.
Platelet reactivity
Time frame: at 24 hours
Platelet reactivity
Time frame: at 3 months
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 20 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Oskar Angerås, 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 2 study testing Ticagrelor 90mg in people with Acute Myocardial Infarction, 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 6 inclusion and 19 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 20 Mar 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Major adverse cardiac event (time frame: within 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2026.