Phase 4
N=112
Chewed Versus Integral Pill of Ticagrelor
Percutaneous Coronary Intervention
Bottom Line
View on ClinicalTrials.gov: NCT03708588 ↗Enrolled (actual)
112
Serious AEs
9.6%
Results posted
Jan 2023
Primary outcome: Primary: Concentration of Pharmacodynamics — 142.5; 210 platelet reaction units
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ticagrelor (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentration of Pharmacodynamics |
142.5; 210 | — |
| SECONDARY Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE) |
4; 2 | — |
| SECONDARY Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE) |
4; 2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- All patients presenting to the cardiac catheterization lab for percutaneous coronary intervention.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03708588). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.