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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clopidogrel and aspirin | Active Comparator | Patients post PCI randomized to Aspirin 80 mg and clopidogrel 75 mg daily |
|
| ticagrelor | Experimental | Patients post PCI randomized to Ticagrelor 90 mg PO two times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aspirin 80 mg and clopidogrel 75 mg daily | Drug | post PCI patients received these two drugs as dual antiplatelet regimen |
|
| Measure | Description | Time Frame |
|---|---|---|
| stent thrombosis | Post PCI till 6 months any confirmed or suspected episodes of stent thrombosis based on ARCH definition | 6 months |
| Major adverse cardiovascular events | Any episodes of myocardial infarction, acute coronary syndrome, revascularization, hospital admission and major vascular events will be recorded | 6 months |
| Bleeding | any major or minor bleeding based on HASBLED criteria | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment related adverse reactions | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| javad UOM Kojuri, MD.MS | Contact | 09171115083 | kojurij@yahoo.com | |
| javad UOM Kojuri, MD.MS. | Contact | 09171115083 | kojurij@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Ward Shiraz University of Medical Sciences | Recruiting | Shiraz | Fars | 51318 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40668853 | Derived | 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. |
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due to patients safety, data will be available on rational request
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Ticagrelor 90 MG | Drug | Post PCI patients receive Ticagrelor 90 mg two times daily as single potent antiplatelet |
|
| professor Kojuroi cardiology clinic | Recruiting | Shiraz | 7134814336 | Iran |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |