Chewed Versus Integral Pill of Ticagrelor
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - 89 |
Updated: | 10/20/2018 |
Start Date: | September 19, 2018 |
End Date: | July 31, 2020 |
Contact: | Thomas F Wilson, MD |
Email: | thomas.wilson@aurora.org |
Phone: | (414) 649-6067 |
Chewed Versus Integral Pill of Ticagrelor in All Patients Undergoing Percutaneous Coronary intervention--a Platelet Reactivity and Patient Outcomes Study.
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.
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.
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 TIMI criteria.
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 TIMI criteria.
Inclusion Criteria:
• All patients presenting to the cardiac catheterization lab for percutaneous coronary
intervention.
Exclusion Criteria:
- 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 GP IIb-IIIa inhibitors 48-hours before the procedure or any use during the
procedure
- Any use of Cangrelor during or after the procedure
- Hemoglobin <10 g/dL, PLT <100x10^9/L
- Pregnancy
- Known allergy to study medication
We found this trial at
1
site
Milwaukee, Wisconsin 53215
Principal Investigator: Thomas Wilson, MD
Phone: 414-649-3512
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