| NCT ID | NCT06509893 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Shiraz University of Medical Sciences |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 5,400 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 5,400 participants in total. It began in 2024-08-01 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06509893 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 80 Years, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06509893 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06509893 currently recruiting?
Yes, NCT06509893 is actively recruiting participants. Contact the research team at kojurij@yahoo.com for enrollment information.
Where is the NCT06509893 trial being conducted?
This trial is being conducted at Shiraz, Iran, Shiraz, Iran.
Who is sponsoring the NCT06509893 clinical trial?
NCT06509893 is sponsored by Shiraz University of Medical Sciences. The trial plans to enroll 5,400 participants.