Coronary Artery DiseasePhase 4TICALONENCT06509893
Ticagrelore Alone Post PCI
A Phase 4 study testing aspirin 80 mg and clopidogrel 75 mg daily and Ticagrelor 90 MG in people with Coronary Artery Disease, run by Shiraz University of Medical Sciences at 2 sites in Iran.
Trial summary
After PCI for CCS patients, single center double blind randomization will be done and patients will receive aspirin 80 mg and clopidogrel 75 mg versus 90 mg two times daily of ticagrelor, for 6 months and MACE will be followed in registry of professor Kojuri cardiology clinic Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- aspirin 80 mg and clopidogrel 75 mg daily and Ticagrelor 90 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,400 participants
- Where
- 2 sitesIran
- Study dates
- 1 Aug 2024to 1 May 2026
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female above 20 years of age undergoing PCI with a drug-eluting stent for chronic coronary syndrome
- The patient has provided written informed consent as approved by the ethics committee of the Shiraz University of Medical Sciences.
Who cannot join
- Contraindication to aspirin, clopidogrel, ticagrelor, or any other reason that study drug should not be administered (including hypersensitivity, moderate or severe liver disease, active bleeding, and major surgery within 30 days)
- Atrial fibrillation or other indication for oral anticoagulant therapy.
- Concomitant oral or IV therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic indices (cyclosporine, and quinidine), or strong CYP3A inducers ( rifampin, rifampicin, phenytoin, and carbamazepine)
- Females of child-bearing age unless negative pregnancy test at screening and willing to use effective contraception for the duration of trial
- Females who are breastfeeding at the time of enrolment.
- Unsuccessful PCI or PCI without optimal stent placement; this decision is made by the supervising interventional cardiologist.
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- patients with anatomical SYNTAX score ≥23 prior to PCI
- Patients with planned surgical intervention to treat any cardiac or non-cardiac condition.
- Previous PCI in the last 6 months.
- Current (same hospitalization) or previous (within 12 months) acute coronary syndrome.
- History of definite stent thrombosis.
- Concomitant cardiac valve disease requiring invasive therapy.
- Acute heart failure.
- Active myocarditis.
- Cardiomyopathy.
- Patient in hemodialysis.
- History of stroke or transient ischemic cerebrovascular accident.
- History of intracranial hemorrhage or other intracranial pathology associated with increased bleeding risk.
- Hemoglobin <10 g/dL
- Peptic ulceration documented by endoscopy within the last 3 months unless healing proven by repeat endoscopy.
- Any other condition deemed by the investigator to place the patient at excessive risk of bleeding with ticagrelor.
- Participation in another trial with an investigational drug or device.
- Assessment that the subject is not likely to comply with the study procedures or have complete follow-up.
- Known drug or alcohol dependence within the past 12 months as judged by the investigator.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Iran2 sites, 2 recruiting
- Recruiting
Cardiology Ward Shiraz University of Medical Sciences
Shiraz, Fars, 51318
javad kojuri, M.D., 00987116318032, kojurij@yahoo.com
javad kojuri, M.D.
- Recruiting
professor Kojuroi cardiology clinic
Shiraz, 7134814336
javad kojuri, MD.MS., +989171115083, kojurij@yahoo.com
javad kojuri, MD.MS., 09171115083, kojurij@yahoo.com
About this study
Official title: A Single-center, Randomized, 6-month, Non-inferiority Study to Compare the Safety and Efficacy of TICAgreLor mONotherapy Versus Dual Antiplatelet Therapy in Chronic Coronary Syndrome Patients Post Percutaneous Coronary IntErvention (TICALONE)
After PCI for CCS patients, single center double blind randomization will be done and patients will receive aspirin 80 mg and clopidogrel 75 mg versus 90 mg two times daily of ticagrelor, for 6 months and MACE will be followed in registry of professor Kojuri cardiology clinic
Read the detailed description
An interventional cardiologist will perform angiography with the supervision of a fellow interventional cardiologist. Patients who need revascularization will undergo PCI using DES (Drug-eluting stent). PCI will be performed using the radial or femoral approach to achieve complete revascularization of at least one stenosis with a diameter of ≥50%. All target lesions will be revascularized using the 4th generation DES.
Randomization (1:1) will take place after diagnostic angiography but before stent insertion (figure 1). Eligible patients will be divided into two groups: the reference group, which will get conventional DAPT with aspirin and Clopidogrel (80 mg aspirin once daily, and 75mg clopidogrel once daily), and the experimental group, which will receive ticagrelor monotherapy (90mg twice daily) following PCI for six months.
Antiplatelet therapy will start before or at the time of PCI. Patients will receive a loading dose of assigned drugs (325mg for aspirin, 300mg for clopidogrel, and 180mg for ticagrelor) before stent insertion unless they are already on pre-PCI maintenance therapy with the mentioned drugs.
Subjects are randomly assigned a treatment strategy by an interactive web response system.
The primary efficacy endpoint is a composite of cardiac death, target vessel MI, stent thrombosis, and the need for revascularization occurring within 6 months of PCI. The secondary endpoints are all-cause death, occurrence of MACE including stroke (ischemic, hemorrhagic, or unknown), MI, arrhythmia, and each component of the primary endpoint at 6 months.
Safety is the third outcome
- Conditions
- Coronary Artery Disease
- Being tested
- aspirin 80 mg and clopidogrel 75 mg daily, Ticagrelor 90 MG
- Keywords
- Percutaneous coronary intervention, dual antiplatelet therapy, clopidogrel, ticagrelor, MACE
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirin 80 mg and clopidogrel 75 mg dailyDrug
post PCI patients received these two drugs as dual antiplatelet regimen
Ticagrelor 90 MGDrug
Post PCI patients receive Ticagrelor 90 mg two times daily as single potent antiplatelet
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel and aspirin | Active comparator | Patients post PCI randomized to Aspirin 80 mg and clopidogrel 75 mg daily Receives: Drug: aspirin 80 mg and clopidogrel 75 mg daily |
| ticagrelor | Experimental | Patients post PCI randomized to Ticagrelor 90 mg PO two times daily Receives: Drug: Ticagrelor 90 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
stent thrombosis
Post PCI till 6 months any confirmed or suspected episodes of stent thrombosis based on ARCH definition
Measured: 6 months
Major adverse cardiovascular events
Any episodes of myocardial infarction, acute coronary syndrome, revascularization, hospital admission and major vascular events will be recorded
Measured: 6 months
Bleeding
any major or minor bleeding based on HASBLED criteria
Measured: 6 months
Secondary outcomes (1)
Treatment related adverse reactions
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start1 Aug 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 May 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 Coronary Artery DiseaseStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 5,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javad Kojuri, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509893
- Sponsor's protocol ID
- IR.SUMS.MED.REC.1403.150
- Acronym
- TICALONE
- Status last verified
- May 2025
- First submitted
- 15 Jul 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: due to patients safety, data will be available on rational request
Publications
Mirhosseini SA, Akbari M, Aldavood D, Zarifkar H, Attar A, Kojuri J. Rationale and design of randomized non-inferiority clinical trial to compare the safety and efficacy of ticagrelor monotherapy with dual antiplatelet therapy in chronic coronary syndrome patients post percutaneous coronary intervention (TICALONE-TAHA10 Protocol). PLoS One. 2025 Jul 16;20(7):e0325663. doi: 10.1371/journal.pone.0325663. eCollection 2025.
PubMed 40668853
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, 6-month, Non-inferiority Study to Compare the Safety and Efficacy of TICAgreLor mONotherapy Versus Dual Antiplatelet Therapy in Chronic Coronary Syndrome Patients Post Percutaneous Coronary IntErvention (TICALONE)
- ClinicalTrials.gov ID
- NCT06509893
- Acronym / sponsor ID
- TICALONE / IR.SUMS.MED.REC.1403.150
- Conditions
- Coronary Artery Disease
- Keywords
- Percutaneous coronary intervention, dual antiplatelet therapy, clopidogrel, ticagrelor, MACE
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,400 participants (estimated)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 19 Jul 2024 (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.
After PCI for CCS patients, single center double blind randomization will be done and patients will receive aspirin 80 mg and clopidogrel 75 mg versus 90 mg two times daily of ticagrelor, for 6 months and MACE will be followed in registry of professor Kojuri cardiology clinic
Detailed description
An interventional cardiologist will perform angiography with the supervision of a fellow interventional cardiologist. Patients who need revascularization will undergo PCI using DES (Drug-eluting stent). PCI will be performed using the radial or femoral approach to achieve complete revascularization of at least one stenosis with a diameter of ≥50%. All target lesions will be revascularized using the 4th generation DES.
Randomization (1:1) will take place after diagnostic angiography but before stent insertion (figure 1). Eligible patients will be divided into two groups: the reference group, which will get conventional DAPT with aspirin and Clopidogrel (80 mg aspirin once daily, and 75mg clopidogrel once daily), and the experimental group, which will receive ticagrelor monotherapy (90mg twice daily) following PCI for six months.
Antiplatelet therapy will start before or at the time of PCI. Patients will receive a loading dose of assigned drugs (325mg for aspirin, 300mg for clopidogrel, and 180mg for ticagrelor) before stent insertion unless they are already on pre-PCI maintenance therapy with the mentioned drugs.
Subjects are randomly assigned a treatment strategy by an interactive web response system.
The primary efficacy endpoint is a composite of cardiac death, target vessel MI, stent thrombosis, and the need for revascularization occurring within 6 months of PCI. The secondary endpoints are all-cause death, occurrence of MACE including stroke (ischemic, hemorrhagic, or unknown), MI, arrhythmia, and each component of the primary endpoint at 6 months.
Safety is the third outcome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel and aspirin | Active comparator | Drug: aspirin 80 mg and clopidogrel 75 mg dailyPatients post PCI randomized to Aspirin 80 mg and clopidogrel 75 mg daily |
| ticagrelor | Experimental | Drug: Ticagrelor 90 MGPatients post PCI randomized to Ticagrelor 90 mg PO two times daily |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female above 20 years of age undergoing PCI with a drug-eluting stent for chronic coronary syndrome
- The patient has provided written informed consent as approved by the ethics committee of the Shiraz University of Medical Sciences.
Key exclusion criteria (24 listed)
- Contraindication to aspirin, clopidogrel, ticagrelor, or any other reason that study drug should not be administered (including hypersensitivity, moderate or severe liver disease, active bleeding, and major surgery within 30 days)
- Atrial fibrillation or other indication for oral anticoagulant therapy.
- Concomitant oral or IV therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic indices (cyclosporine, and quinidine), or strong CYP3A inducers ( rifampin, rifampicin, phenytoin, and carbamazepine)
- Females of child-bearing age unless negative pregnancy test at screening and willing to use effective contraception for the duration of trial
- Females who are breastfeeding at the time of enrolment.
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 |
|---|---|---|
| aspirin 80 mg and clopidogrel 75 mg dailypost PCI patients received these two drugs as dual antiplatelet regimen | Drug | Clopidogrel and aspirin |
| Ticagrelor 90 MGPost PCI patients receive Ticagrelor 90 mg two times daily as single potent antiplatelet | Drug | ticagrelor |
Primary outcome
stent thrombosis
Time frame: 6 months
Post PCI till 6 months any confirmed or suspected episodes of stent thrombosis based on ARCH definition
Major adverse cardiovascular events
Time frame: 6 months
Any episodes of myocardial infarction, acute coronary syndrome, revascularization, hospital admission and major vascular events will be recorded
Bleeding
Time frame: 6 months
any major or minor bleeding based on HASBLED criteria
1 secondary outcome
Treatment related adverse reactions
Time frame: 6 months
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 21 May 2025.
- Derived from this study: PubMed 40668853Mirhosseini SA, Akbari M, Aldavood D, Zarifkar H, Attar A, Kojuri J. Rationale and design of randomized non-inferiority clinical trial to compare the safety and efficacy of ticagrelor monotherapy with dual antiplatelet therapy in chronic coronary syndrome patients post percutaneous coronary intervention (TICALONE-TAHA10 Protocol). PLoS One. 2025 Jul 16;20(7):e0325663. doi: 10.1371/journal.pone.0325663. eCollection 2025.
- Individual participant dataSharing planned: No. due to patients safety, data will be available on rational request
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aspirin 80 mg and clopidogrel 75 mg daily and Ticagrelor 90 MG in people with Coronary Artery Disease, run by Shiraz University of Medical Sciences at 2 sites in Iran.
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 24 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: looking for participants now, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. 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?
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 javad UOM Kojuri, MD.MS (09171115083, kojurij@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stent thrombosis (time frame: 6 months). The study lists 3 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 NCT06509893, 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 21 May 2025.