Chewed Versus Integral Pill of Ticagrelor

Wake Forest University (WFU)

Status and phase: Completed; Phase 4

Conditions: Percutaneous Coronary Intervention

Treatments: Drug: Ticagrelor

Study type: Interventional

Funder types: Other

Identifiers

NCT03708588

18-078_18-911

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Experimental: Chewed ticagrelor

Experimental group

Description:

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)

Treatment:

Drug: Ticagrelor

Drug: Ticagrelor

Active Comparator: Integral pill

Active Comparator group

Description:

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)

Treatment:

Drug: Ticagrelor

Drug: Ticagrelor