Acute Myocardial Infarction Clinical Trial
Official title:
The Early De-escalation Strategy With Ticagrelor 60 mg or 45 mg on Platelet Reactivity and Clinical Outcomes in Korean Patients With Acute Myocardial Infarction
East Asian patients will be required optimal dose of newer P2Y12 inhibitor (ticagrelor) to determine the safer treatment and better outcome. Whether low dose of ticagrelorI is more adequate for clinical practice in Korea is unclear. Therefore, the investigators aim to evaluate efficacy and safety of low dose of ticagrelor in Acute Myocardial Infarction (AMI) undergoing percutaneous coronary intervention(PCI).
Status | Recruiting |
Enrollment | 120 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility | Inclusion Criteria: - Patients present with acute myocardial infarction undergoing PCI. - Patients receiving ticagrelor; Male or female gender; Age 20-75 years. - Patients provide written informed consent prior to enrollment. Exclusion Criteria: - Low body weight (<60kg). - History of hemorrhagic stroke. - History of upper gastrointestinal bleeding in recent 6 months. - Bleeding tendency. - Thrombocytopenia defined by platelet < 100,000/ml. - Anemia defined by hemoglobin < 10 g/dl. - Renal dysfunction defined as serum creatinine > 2.5 mg/dl. - Severe hepatic dysfunction defined as serum transaminase > 3 times normal limit. - Known severe chronic obstructive pulmonary disease or bradycardia (sick sinus syndrome (SSS) or high degree AV block without pacemaker protection). - Current treatment with drugs interfering with CYP3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | DongA University Hospital | Busan |
Lead Sponsor | Collaborator |
---|---|
Dong-A University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Optimal platelet reactivity (OPR) rate | OPR, indicate 85 to 208 for P2Y12 reaction units (PRU) | At 1 month | |
Secondary | Major adverse cardiac and cerebrovascular events (MACCE) | MACCE: composite of cardiac death, non-fatal myocardial infarction, target lesion / vessel revascularization and stroke | At 9 months | |
Secondary | Bleeding events | BARC: Bleeding Academic Research Consortium (BARC =2). | At 9 months. |
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