Chewed Versus Integral Pill of Ticagrelor

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-19

Study Completion Date

2021-07-31

Brief Summary

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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.

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Detailed Description

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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

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Percutaneous Coronary Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental: Chewed ticagrelor

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)

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

Chewed

Active Comparator: Integral pill

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)

Group Type ACTIVE_COMPARATOR

Ticagrelor

Intervention Type DRUG

Integral

Interventions

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Ticagrelor

Chewed

Intervention Type DRUG

Ticagrelor

Integral

Intervention Type DRUG

Other Intervention Names

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Brilinta Brilique Possia Brilinta Brilique Possia

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No