chronic coronary syndrome. Chronic ischemic heart disease
Conditions
Interventions
Intervention 1: Intervention group: Ticagrelor monotherapy after PCI. Intervention 2: Control group: conventional dual anti-platelet therapy.
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: Male or female above 20 years of age undergoing PCI with a drug-eluting stent for treating chronic coronary syndrome. The patient has provided written informed consent as approved by the ethics committee.
Exclusion criteria
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. 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. Patients with acute heart failure, active myocarditis, or 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. Patients with planned surgical intervention to treat any cardiac or non-cardiac condition. Unsuccessful PCI or PCI without optimal stent placement; this decision is made by the supervising interventional cardiologist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stent thrombosis. Timepoint: 1, 3, 6, and 12 months post PCI. Method of measurement: History and physical examinations indicating the need for revascularization.;Bleeding (BARC type 3 to 5). Timepoint: 1, 3, 6, and 12 months post PCI. Method of measurement: History and physical exam. | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Adverse Cardiovascular Event (MACE). Timepoint: 1, 3, 6, and 12 months post PCI. Method of measurement: Interview.;All-cause death. Timepoint: 1, 3, 6, and 12 months post PCI. Method of measurement: Interview. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSeyed Alireza Mirhosseini
Shiraz University of Medical Sciences
Outcome results
None listed