Clinical trial NCT03708588: Chewed Versus Integral Pill of Ticagrelor
Official title: Chewed Versus Integral Pill of Ticagrelor in All Patients Undergoing Percutaneous Coronary intervention--a Platelet Reactivity and Patient Outcomes Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Percutaneous Coronary Intervention
Keywords: Ticagrelor
Stent
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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 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

Primary outcomes:
measure: Concentration of Pharmacodynamics
timeFrame: 1 hour
Secondary outcomes:
measure: Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE)
timeFrame: 30 days
measure: Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE)
timeFrame: 1 year
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Aurora Health Care, St. Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: Wake Forest University Health Sciences
name: Suhail Allaqaband, MD
role: PRINCIPAL_INVESTIGATOR
References: