NCT03708588

Chewed Versus Integral Pill of Ticagrelor

Chewed Versus Integral Pill of Ticagrelor in All Patients Undergoing Percutaneous Coronary intervention--a Platelet Reactivity and Patient Outcomes Study.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
DRUG	Ticagrelor	Chewed
DRUG	Ticagrelor	Integral

Timeline

• Start date: 2018-09-19
• Primary completion: 2020-12-31
• Completion: 2021-07-31
• First posted: 2018-10-17
• Last updated: 2024-10-03
• Results posted: 2023-01-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study