RecruitingPhase 4NCT06509893

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)

Sponsor

Shiraz University of Medical Sciences

Enrollment

5,400 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Coronary Artery Disease

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

Min Age: 20 YearsMax Age: 80 Years

Inclusion Criteria2

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 Criteria24

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.