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Fentanyl and Crushed Ticagrelor in Percutaneous Coronary Intervention (FACTPCI)

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ClinicalTrials.gov Identifier: NCT03476369
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
The Guthrie Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Percutaneous Coronary Intervention Drug: Fentanyl Drug: Ticagrelor 90Mg Tablet Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Patients Undergoing Percutaneous Coronary Intervention Who Receive Ticagrelor and Fentanyl
Actual Study Start Date : April 18, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fentanyl and Crushed Ticagrelor
Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered crushed (180 mg dose)
Drug: Fentanyl
Premedicated with Fentanyl (at least 25mcg by IV)

Drug: Ticagrelor 90Mg Tablet
Ticagrelor administered crushed vs non-crushed

Active Comparator: 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)
Drug: Fentanyl
Premedicated with Fentanyl (at least 25mcg by IV)

Drug: Ticagrelor 90Mg Tablet
Ticagrelor administered crushed vs non-crushed




Primary Outcome Measures :
  1. Platelet Function Testing [ Time Frame: 12 hours ]
    Platelet vasodilator-stimulated phosphoprotein assay


Secondary Outcome Measures :
  1. Stent thrombosis [ Time Frame: 30 days ]
  2. Recurrent myocardial infarction [ Time Frame: 30 days ]
  3. All-cause mortality [ Time Frame: 30 days ]
  4. Stroke [ Time Frame: 30 days ]
  5. TIMI minor and major [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03476369


Contacts
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Contact: Sudhakar Sattur, MD 570-887-6072 Sudhakar.Sattur@guthrie.org

Locations
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United States, Pennsylvania
The Guthrie Clinic Recruiting
Sayre, Pennsylvania, United States, 18840
Contact: Vicky Hickey    570-887-4882    Vicky.Hickey@guthrie.org   
Principal Investigator: Sudhakar Sattur, MD         
Sponsors and Collaborators
The Guthrie Clinic

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Responsible Party: The Guthrie Clinic
ClinicalTrials.gov Identifier: NCT03476369     History of Changes
Other Study ID Numbers: 1801-05
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Fentanyl
Ticagrelor
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action