NCT06509893RecruitingPhase 4
Ticagrelore Alone Post PCI
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)
Source: ClinicalTrials.gov · Last updated 21 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 5400 (estimated)
- First submitted
- 15 Jul 2024
- Start date
- 1 Aug 2024
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- Shiraz University of Medical Sciences
- Diseases
- Coronary artery disease
- NCT number
- NCT06509893
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 5400
- From 1 Aug 2024 to the primary completion date, 1 Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- patients with anatomical SYNTAX score ≥23 prior to PCI
- Previous PCI in the last 6 months.
- Current (same hospitalization) or previous (within 12 months) acute coronary syndrome.
- Concomitant cardiac valve disease requiring invasive therapy.
- Participation in another trial with an investigational drug or device.
- Known drug or alcohol dependence within the past 12 months as judged by the investigator.
Other illness
- 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)
- Patients with planned surgical intervention to treat any cardiac or non-cardiac condition.
- History of definite stent thrombosis.
- Acute heart failure.
- History of stroke or transient ischemic cerebrovascular accident.
- History of intracranial hemorrhage or other intracranial pathology associated with increased bleeding risk.
- Any other condition deemed by the investigator to place the patient at excessive risk of bleeding with ticagrelor.
Lab values
- Hemoglobin \<10 g/dL
Age
- Females of child-bearing age unless negative pregnancy test at screening and willing to use effective contraception for the duration of trial
Other
- 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.
- Active myocarditis.
- Cardiomyopathy.
- Patient in hemodialysis.
- Peptic ulceration documented by endoscopy within the last 3 months unless healing proven by repeat endoscopy.
- Assessment that the subject is not likely to comply with the study procedures or have complete follow-up.
Who the study is looking for
- 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.
Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| professor Kojuroi cardiology clinic Coordinator of this site? Confirm its status | Shiraz | Iran | Recruiting |
| Cardiology Ward Shiraz University of Medical Sciences Coordinator of this site? Confirm its status | Shiraz | Iran | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.