To compare platelet inhibition with crushed versus whole tablet administration of clopidogrel and ticagrelor in patients with acute coronary syndrome undergoing percutaneous intervention procedure.
Phase 3
- Conditions
- Health Condition 1: I22- Subsequent ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
- Registration Number
- CTRI/2020/06/025647
- Lead Sponsor
- Fluid Research Fund
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients presenting within 12 hours from the onset of symptoms with ACS as per ACC/AHA criteria and undergoing PCI.
Patients giving informed consent obtained in writing.
Exclusion Criteria
Age < 18 years or Age > 75 years.
Inability to give informed consent.
Active bleeding; bleeding diathesis; coagulopathy
History of GI, I.C, genitourinary or other site abnormal bleeding < 3 months
Suspected aortic dissection
Known relevant hematological deviations: Hb <10 g/dl, Platelets <50000.
Known severe liver disease, severe renal failure
Pregnancy/breastfeeding.
Allergy / Hypersensitivity.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Residual Platelet Reactivity by Platelet Reactivity Units (PRU) in the 4 groupsTimepoint: Time Frame: 1 hour after loading dose
- Secondary Outcome Measures
Name Time Method Bleeding EventsTimepoint: Time Frame: 48 hours;High Residual Platelet Reactivity/antiplatelet resistanceTimepoint: Time Frame: 1 hour;Patient comfort during administration of loading dose by Visual Analogue Scale (VAS) â?? scored from 0-10Timepoint: after loading dose