Antiplatelet Effects of Tirofiban vs. Cangrelor N-STEMI Patients Undergoing Percutaneous Coronary Intervention
NCT ID: NCT03048019
Last Updated: 2023-12-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
10 participants
OBSERVATIONAL
2017-08-23
2019-06-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Tirofiban Therapy
patients randomized to tirofiban therapy
Tirofiban
Patients will receive Tirofiban during the PCI procedure
Cangrelor Therapy
patients randomized to cangrelor therapy
Cangrelor
Patients will receive Cangrelor during the PCI procedure
Interventions
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Tirofiban
Patients will receive Tirofiban during the PCI procedure
Cangrelor
Patients will receive Cangrelor during the PCI procedure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Patients 18 years of age or older with one or more of the following symptoms:
* new ST-segment depression or transient elevation of at least 1 mm
* elevations in troponin I, troponin T, or creatine kinase MB levels above ULN
2. Eligible for ticagrelor, cangrelor, aspirin, UFH, and GP IIb/IIIa inhibitor treatment.
3. Admitted at cardiac catheterization laboratory hospital or associated facility.
4. Competent mental condition to provide informed consent.
Exclusion Criteria
2. Cardiogenic shock
3. Refractory ventricular arrhythmias
4. New York Heart Association class IV congestive heart failure
5. Cardiac arrest within 1 week of study entry
6. History of hemorrhagic or ischemic stroke, TIA, sub-arachnoid hemorrhage or intracranial neoplasm, arteriovenous malformation, or aneurysm
7. Fibrinolytic therapy within 48 hours of study entry
8. Active pathological bleeding or history of bleeding diathesis
9. Severe hepatic insufficiency
10. Current peptic ulceration
11. Increased bleeding risk, per investigator judgment
12. Known anemia (hematocrit\<25%)/thrombocytopenia (platelet count \< 100,000mm3)
13. Surgery within 4 weeks before study entry or planned surgery within 2 months after study entry
14. Any P2Y12 receptor inhibitor or GP IIb/IIIa inhibitor within 7 days of study entry
15. Receiving warfarin or other coumadin derivatives or NOACs within the last 10 days with an INR \>1.5 secs or planned use during the hospitalization period
16. Contraindication to the use of ticagrelor and/or aspirin
17. Receiving or will receive oral anticoagulation or other oral antiplatelet therapy (except aspirin) that cannot be safely discontinued within the next 3 months
18. Receiving daily NSAIDs or COX2 inhibitors that cannot be discontinued or anticipated to require \>2 weeks of daily NSAIDs or COX2 inhibitors during study
19. Investigational drug in last 30 days or presently enrolled in drug/device study
20. Women of childbearing potential (post-menopausal women can be enrolled if at least 1 year of amenorrhea or surgically sterile)
21. Condition associated with poor treatment compliance (e.g., alcoholism, mental illness, or drug dependence)
22. Inability to provide written informed consent and to understand the full meaning of the informed consent
18 Years
ALL
No
Sponsors
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Inova Health Care Services
OTHER
Responsible Party
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Principal Investigators
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Paul Gurbel, MD
Role: PRINCIPAL_INVESTIGATOR
Inova Health Care Services
Locations
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Inova Health Care System
Falls Church, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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17-2617
Identifier Type: -
Identifier Source: org_study_id