Chewed Versus Integral Pill of Ticagrelor
- Registration Number
- NCT03708588
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
Hypothesis The primary question the investigators propose to answer is whether all patients undergoing percutaneous coronary intervention (PCI) with stent deployment who receive chewed ticagrelor will demonstrate more rapid drug absorption and decreased platelet reactivity as compared to integral pill form 1 hour after drug administration.
- Detailed Description
Hypothesis The primary question the investigators propose to answer is whether all patients undergoing PCI with stent deployment who receive chewed ticagrelor will demonstrate more rapid drug absorption and decreased platelet reactivity as compared to integral pill form 1 hour after drug administration.
Secondary Hypotheses:
1. Major adverse cardiac and cerebrovascular event (MACCE) rate at 30 days and 1 year.
1. Death
2. Repeat myocardial infarction
3. Need for urgent revascularization
4. Cerebrovascular accident
2. Rate of stent thrombosis and in-stent stenosis at 30 days and 1 year.
3. Bleeding: Defined as major, minor, or minimal bleeding based on thrombolysis in myocardial infarction (TIMI) criteria.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
• All patients presenting to the cardiac catheterization lab for percutaneous coronary intervention.
- Age <18 years or Age >89 years
- Known coagulopathy, bleeding diathesis, or active bleeding
- History of recent gastrointestinal or genitourinary bleed within 2 months
- Known chronic therapy with clopidogrel, prasugrel, or ticagrelor
- Major surgery within last 6 weeks
- History of intracranial bleed or intracranial neoplasm
- Suspected aortic dissection
- Severe hemodynamic instability, cardiogenic shock
- Life expectancy <1 year
- Known severe liver or renal disease
- Known HIV treatment
- Any use of Glycoprotein inhibitors (GP IIb-IIIa) 48-hours before the procedure or any use during the procedure
- Any use of Cangrelor during or after the procedure
- Hemoglobin <10 g/dL, platelet (PLT) <100x10^9/L
- Pregnancy
- Known allergy to study medication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental: Chewed ticagrelor Ticagrelor Drug: Ticagrelor chewed pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline P2Y12 platelet reaction units (PRU) level is drawn and before the end of the PCI. Patients will be asked to chew, but not swallow, allowing for sublingual absorption. (Loading dose 180mg) Active Comparator: Integral pill Ticagrelor Drug: Ticagrelor integral pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline P2Y12 platelet reaction units (PRU) level is drawn and before the end of the PCI. Patients will swallow the loading dose followed by 25-50mL (milliliter) of water. (180mg)
- Primary Outcome Measures
Name Time Method Concentration of Pharmacodynamics 1 hour Platelet function was measured using the VerifyNow P2Y12 Assay (Accumetrics, San Diego, CA). This test is a turbidimetric-based optical detection system that measures ADP (Adenosine diphosphate) - induced platelet agglutination using a proprietary algorithm to report values in PRU.
- Secondary Outcome Measures
Name Time Method Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE) 1 year Measure events such as: death, repeat myocardial revascularization, cerebrovascular accident, stent thrombosis, in-stent stenosis and bleeding.
Trial Locations
- Locations (1)
Aurora Health Care, St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States