Chronic Coronary SyndromePhase 4STELARNCT07080684
Short-Term Dual Antiplatelet Therapy With Early Transi-tion to Low-dose Antiplatelet Monotherapy Using Ti-cagRelor in Chronic Coronary Artery Disease
A Phase 4 study testing Ticagrelor 60 mg and clopidogrel 75 mg in people with Chronic Coronary Syndrome, run by University of Messina.
Trial summary
This is a prospective, multicenter, randomized, open-label trial with blinded endpoint adjudication (PROBE design), comparing one-month dual antiplatelet therapy (DAPT) with low-dose ticagrelor (60 mg BID) followed by ticagrelor monotherapy to standard 6-month DAPT with aspirin and clopidogrel in patients with chronic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Coronary Syndrome
- What is being tested?
- Ticagrelor 60 mg and clopidogrel 75 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to Sep 2028
- Phase
- Phase 4
- 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
- Age ≥18 years at the time of informed consent.
- Diagnosis of chronic coronary syndrome (CCS) according to ESC guidelines.
- Undergoing successful PCI with implantation of one or more new-generation drug-eluting stents (DES).
- Indication for dual antiplatelet therapy (DAPT) following PCI.
- Willingness and ability to comply with all study procedures and follow-up assessments.
- Signed informed consent prior to any study-specific procedure.
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- Creatinine clearance ≥30 mL/min, calculated using the Cockcroft-Gault formula.
- Life expectancy greater than 1 year in the investigator's judg-ment.
- Hemodynamically stable at the time of randomization.
- Acceptable bleeding risk profile: patients fulfilling ARC-HBR criteria may be included only if the treating physician deems a 6-month antiplatelet regimen to be safe.
- No contraindications to study drugs, including aspirin, clopi-dogrel, or ticagrelor.
Who cannot join
- Presentation with acute coronary syndrome (ACS), including STEMI, NSTEMI, or unstable angina within the previous 6 mon-ths.
- Planned staged PCI or revascularization procedure within 6 months after index PCI.
- Requirement for long-term oral anticoagulation therapy, such as for atrial fibrillation, mechanical heart valves, or venous thromboembolism.
- History of major bleeding, including gastrointestinal or intra-cranial bleeding, within the past 6 months.
- Severe hepatic impairment, active liver disease, or transamina-ses >3× upper limit of normal.
- Known platelet disorder, coagulopathy, or thrombocytopenia (<100,000/mm³).
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- Contraindication or hypersensitivity to aspirin, clopidogrel, or ticagrelor, or known drug interaction that precludes their use.
- Ongoing active bleeding or high risk of bleeding that, in the opinion of the investigator, precludes DAPT.
- Pregnancy or breastfeeding, or women of childbearing potential who are not using effective contraception.
- Life expectancy <1 year due to non-cardiovascular comorbidi-ties (e.g., cancer, advanced renal failure).
- Participation in another interventional clinical trial that may interfere with the outcomes of this study.
- Severe anemia (hemoglobin <9 g/dL) not corrected before ran-domization.
- Inability or unwillingness to provide informed consent or ad-here to study follow-up.
- Prior stroke with residual neurological deficit or history of di-sabling stroke (mRS ≥3).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Short-Term Dual Antiplatelet Therapy With Early Transition to Low-dose Antiplatelet Monotherapy Using ticagRelor in Chronic Coronary Artery Disease
This is a prospective, multicenter, randomized, open-label trial with blinded endpoint adjudication (PROBE design), comparing one-month dual antiplatelet therapy (DAPT) with low-dose ticagrelor (60 mg BID) followed by ticagrelor monotherapy to standard 6-month DAPT with aspirin and clopidogrel in patients with chronic coronary syndrome (CCS) undergoing percutaneous coronary intervention (PCI). The primary endpoint is a composite of cardiovascular death, all-cause death, myocardial infarction, disabling stroke, target lesion revascularization (TLR), and major bleeding. The study aims to evaluate whether the short DAPT strategy reduces ischemic events while maintaining bleeding safety.
- Conditions
- Chronic Coronary Syndrome
- Being tested
- Ticagrelor 60 mg, clopidogrel 75 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor 60 mgDrug
Patients in this arm will receive dual antiplatelet therapy (DAPT) consisting of low-dose ticagrelor (60 mg twice daily) plus aspirin (75-100 mg once daily) for 1 month, followed by ticagrelor 60 mg monotherapy for 5 additional months (total 6 months of therapy).
This strategy aims to reduce ischemic events while minimizing bleeding risk by leveraging the potent antiplatelet effect of ticagrelor at a lower maintenance dose.
clopidogrel 75 mgDrug
Patients in the control group will receive standard DAPT consisting of clopidogrel 75 mg once daily plus aspirin 75-100 mg once daily for 6 months.
This represents the current standard of care in patients with chronic coronary syndrome (CCS) undergoing percutaneous coronary intervention (PCI) with drug-eluting stents.
| Study group | Role | What they receive |
|---|---|---|
| Short DAPT with Ticagrelor 60 mg | Experimental | * 1-month DAPT: aspirin + ticagrelor 60 mg BID
* Followed by 5-month ticagrelor 60 mg BID monotherapy
* Ticagrelor will be provided by the sponsor (off-label use) Receives: Drug: Ticagrelor 60 mg |
| Standard DAPT with Clopidogrel | Active comparator | - 6-month DAPT: aspirin + clopidogrel 75 mg daily Receives: Drug: clopidogrel 75 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of cardiovascular death, myocardial infarction, disabling stroke, target lesion revascularization, major bleeding, and all-cause death
Number of participants experiencing any of the following events within 12 months after the index percutaneous coronary intervention (PCI):
- Cardiovascular death - Number of participants with death due to a cardiovascular cause
- Non-fatal myocardial infarction - Number of participants with myocardial infarction as defined by the Fourth Universal Definition
- Non-fatal disabling stroke - Number of participants with stroke resulting in a modified Rankin Scale (mRS) ≥2
- Target lesion revascularization (TLR) - Number of participants undergoing clinically driven revascularization of the target lesion
- Major bleeding - Number of participants experiencing major bleeding events defined as BARC type 3 or 5
- All-cause death - Number of participants who died from any cause
Measured: 6 month
Secondary outcomes (8)
Cardiovascular Death
death due to myocardial infarction, sudden cardiac death, stroke, heart failure, or other vascular causes, as adjudicated by investigators.
Measured: 6 month
All cause death
death from any cause, cardiovascular or non-cardiovascular.
Measured: 6 month
Myocardial Infarction
Defined according to ARC-2 criteria as either spontaneous (type 1), peri-procedural (type 4a/4b), or stent thrombosis-related, confirmed by clinical symp-toms, ECG changes, and biomarker elevation.
Measured: 6 month
Major Bleeding (BARC ≥3)
Bleeding events classified as Bleeding Academic Research Consortium (BARC) type 3a (overt bleeding with hemoglobin drop ≥3 g/dL), 3b (requiring in-tervention or surgery), 3c (intracranial or intraocular), or type 5 (fatal bleeding).
Measured: 6 month
Disabling Stroke
New-onset neurologic deficit confirmed by imaging and persisting beyond 24 hours, with a modified Rankin Score (mRS) ≥2.
Measured: 6 month
Target Lesion Revascularization (TLR)
Repeat revascularization (PCI or CABG) of the originally treated lesion due to restenosis or thrombosis.
Measured: 6 month
Target Vessel Revascularization (TVR)
Any repeat PCI or CABG of the same vessel previously treated, regardless of lesion location.
Measured: 6 month
Any Ischemic Event
Composite of MI, ischemic stroke, or TLR.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start1 Nov 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Coronary SyndromeStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Messina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodolfo Caminiti, University of Messina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080684
- Sponsor's protocol ID
- STELAR_CCS_0725
- Acronym
- STELAR
- Status last verified
- Sep 2026
- First submitted
- 3 Jul 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Dual Antiplatelet Therapy With Early Transition to Low-dose Antiplatelet Monotherapy Using ticagRelor in Chronic Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT07080684
- Acronym / sponsor ID
- STELAR / STELAR_CCS_0725
- Conditions
- Chronic Coronary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of MessinaUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 23 Jul 2025 (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 is a prospective, multicenter, randomized, open-label trial with blinded endpoint adjudication (PROBE design), comparing one-month dual antiplatelet therapy (DAPT) with low-dose ticagrelor (60 mg BID) followed by ticagrelor monotherapy to standard 6-month DAPT with aspirin and clopidogrel in patients with chronic coronary syndrome (CCS) undergoing percutaneous coronary intervention (PCI). The primary endpoint is a composite of cardiovascular death, all-cause death, myocardial infarction, disabling stroke, target lesion revascularization (TLR), and major bleeding. The study aims to evaluate whether the short DAPT strategy reduces ischemic events while maintaining bleeding safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short DAPT with Ticagrelor 60 mg | Experimental | Drug: Ticagrelor 60 mg* 1-month DAPT: aspirin + ticagrelor 60 mg BID * Followed by 5-month ticagrelor 60 mg BID monotherapy * Ticagrelor will be provided by the sponsor (off-label use) |
| Standard DAPT with Clopidogrel | Active comparator | Drug: clopidogrel 75 mg- 6-month DAPT: aspirin + clopidogrel 75 mg daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years at the time of informed consent.
- Diagnosis of chronic coronary syndrome (CCS) according to ESC guidelines.
- Undergoing successful PCI with implantation of one or more new-generation drug-eluting stents (DES).
- Indication for dual antiplatelet therapy (DAPT) following PCI.
- Willingness and ability to comply with all study procedures and follow-up assessments.
Key exclusion criteria (14 listed)
- Presentation with acute coronary syndrome (ACS), including STEMI, NSTEMI, or unstable angina within the previous 6 mon-ths.
- Planned staged PCI or revascularization procedure within 6 months after index PCI.
- Requirement for long-term oral anticoagulation therapy, such as for atrial fibrillation, mechanical heart valves, or venous thromboembolism.
- History of major bleeding, including gastrointestinal or intra-cranial bleeding, within the past 6 months.
- Severe hepatic impairment, active liver disease, or transamina-ses >3× upper limit of normal.
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 60 mgPatients in this arm will receive dual antiplatelet therapy (DAPT) consisting of low-dose ticagrelor (60 mg twice daily) plus aspirin (75-100 mg once daily) for 1 month, followed by ticagrelor 60 mg monotherapy for 5 additional months (total 6 months of therapy). This strategy aims to reduce ischemic events while minimizing bleeding risk by leveraging the potent antiplatelet effect of ticagrelor at a lower maintenance dose. | Drug | Short DAPT with Ticagrelor 60 mg |
| clopidogrel 75 mgPatients in the control group will receive standard DAPT consisting of clopidogrel 75 mg once daily plus aspirin 75-100 mg once daily for 6 months. This represents the current standard of care in patients with chronic coronary syndrome (CCS) undergoing percutaneous coronary intervention (PCI) with drug-eluting stents. | Drug | Standard DAPT with Clopidogrel |
Primary outcome
Composite of cardiovascular death, myocardial infarction, disabling stroke, target lesion revascularization, major bleeding, and all-cause death
Time frame: 6 month
Number of participants experiencing any of the following events within 12 months after the index percutaneous coronary intervention (PCI): * Cardiovascular death - Number of participants with death due to a cardiovascular cause * Non-fatal myocardial infarction - Number of participants with myocardial infarction as defined by the Fourth Universal Definition * Non-fatal disabling stroke - Number of participants with stroke resulting in a modified Rankin Scale (mRS) ≥2 * Target lesion revascularization (TLR) - Number of participants undergoing clinically driven revascularization of the target lesion * Major bleeding - Number of participants experiencing major bleeding events defined as BARC type 3 or 5 * All-cause death - Number of participants who died from any cause
8 secondary outcomes
Cardiovascular Death
Time frame: 6 month
All cause death
Time frame: 6 month
Myocardial Infarction
Time frame: 6 month
Major Bleeding (BARC ≥3)
Time frame: 6 month
Disabling Stroke
Time frame: 6 month
Target Lesion Revascularization (TLR)
Time frame: 6 month
Target Vessel Revascularization (TVR)
Time frame: 6 month
Any Ischemic Event
Time frame: 6 month
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 15 Sep 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ticagrelor 60 mg and clopidogrel 75 mg in people with Chronic Coronary Syndrome, run by University of Messina.
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 11 inclusion and 14 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: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Contact Rodolfo Caminiti (+393286911102, rodolfocaminiti@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of cardiovascular death, myocardial infarction, disabling stroke, target lesion revascularization, major bleeding, and all-cause death (time frame: 6 month). 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 15 Sep 2026.