Fentanyl and Crushed Ticagrelor in Percutaneous Coronary Intervention

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-18

Study Completion Date

2025-01-23

Brief Summary

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During a percutaneous coronary intervention (PCI), Fentanyl is commonly used for sedation. Ticagrelor is also routinely used as anti-platelet agent during PCI. However, a recent study has demonstrated the decrease in effectiveness of Ticagrelor when administered along with Fentanyl. Hence this study was designed to further assess the interaction between crushed vs non crushed Ticagrelor and Fentanyl given during PCI procedures.

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Detailed Description

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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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Fentanyl and Crushed Ticagrelor

Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered crushed (180 mg dose)

Group Type EXPERIMENTAL

Fentanyl

Intervention Type DRUG

Premedicated with Fentanyl (at least 25mcg by IV)

Ticagrelor 90Mg Tablet

Intervention Type DRUG

Ticagrelor administered crushed vs non-crushed

Fentanyl and Non-crushed Ticagrelor

Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered as a whole tablet (180 mg dose)

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

Premedicated with Fentanyl (at least 25mcg by IV)

Ticagrelor 90Mg Tablet

Intervention Type DRUG

Ticagrelor administered crushed vs non-crushed

Interventions

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Fentanyl

Premedicated with Fentanyl (at least 25mcg by IV)

Intervention Type DRUG

Ticagrelor 90Mg Tablet

Ticagrelor administered crushed vs non-crushed

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Undergoing clinically indicated elective or non-elective PCI
* Able to swallow oral medications

Exclusion Criteria

* Contraindications to ticagrelor or fentanyl (or other opiates)
* Pregnancy
* Any use of P2Y12 inhibitors within 14 days
* Known coagulation disorders
* Pre-procedural treatment with an anticoagulant (oral anticoagulant or low molecular weight heparin)
* Platelet count \< 100,000/mm3
* Impaired renal function (Estimated glomerular filtration \< 45 ml/min/1.73 m2)
* Impaired hepatic function (Based on medical history)
* Prior or planned transcatheter aortic valve replacement

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No