Status:
UNKNOWN
LOwer Maintenance Dose TICagrelor in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention
Lead Sponsor:
Beijing Anzhen Hospital
Conditions:
Antiplatelet Therapy
Coronary Artery Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The hypothesis in this study was that ticagrelor switched to 60 mg after 1 month of standard dose, with antiplatelet activity that is not inferior to the standard dose and better than 75 mg clopidogre...
Eligibility Criteria
Inclusion
- Agree to sign the Informed Consent;
- Male or female, ≥ 18 years of age, and ≤ 70 years of age
- Patient presents with acute coronary syndrome (ACS)
- Planned to undergo PCI
- Planned to DAPT for 1 year after PCI
Exclusion
- Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization or planned use of investigational agents or devices prior to the Day 30 visit.
- Patients cannot use ticagrelor or clopidogrel due to contraindications or other reasons.
- Patients with active pathological hemorrhage or a history of intracranial hemorrhage
- Patient unable to receive 12 months of dual anti-platelet therapy
- Patient developing procedure-related complications such as stent thrombosis, coronary dissection, coronary perforation, cardiac tamponade or no-reflow during PCI
- Patient or physician refusal to enroll in the study
- History of intracranial hemorrhage
- Patient has a history of bleeding diathesis or coagulopathy
- Patient has an active pathological bleeding, such as active gastrointestinal (GI) bleeding
- Patient is pregnant, breastfeeding, or planning to become pregnant within 12 months
- Patient is receiving chronic oral anticoagulation therapy (i.e., vitamin K antagonist, direct thrombin inhibitor, Factor Xa inhibitor)
- Patient with cardiogenic shock or mechanical circulatory assist devices placed
- Patient with active liver diseases
- Patient with severe renal insufficiency (eGFR \<30ml/min/1.73m2 based on simplified MDRD equation or CrCl \<30ml/min based on Cockcroft-Gault equation)
- Patient has a malignancy or a life expectancy of less than one year
- Platelet count \<100 000/μL, or hematocrit \<32% or \>52%, or white blood cell count \<3000/μL
- Any other condition deemed by the investigator to place the patient at excessive risk of bleeding with ticagrelor
Key Trial Info
Start Date :
August 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT04060914
Start Date
August 30 2019
End Date
December 30 2021
Last Update
August 19 2019
Active Locations (1)
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1
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China, 100029