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Trial record 10 of 28 for:    cangrelor

Comparison of Pharmacodynamic Effects of Tirofiban vs. Cangrelor in N-STEMI Patients Undergoing Percutaneous Coronary Intervention

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ClinicalTrials.gov Identifier: NCT03048019
Recruitment Status : Recruiting
First Posted : February 9, 2017
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Inova Health Care Services

Brief Summary:
Immediate potent inhibition of platelet function is critical for the prevention of periprocedural ischemic event occurrences in high risk N-ST segment elevation myocardial infarction (NSTEMI) in patients undergoing percutaneous coronary intervention (PCI). Currently, dual antiplatelet therapy with aspirin and an oral P2Y12 receptor blocker (with loading doses) is widely used for PCI. However, immediate, potent and reversible inhibition of platelet aggregation is not possible even with the newer oral agents, prasugrel and ticagrelor. Therefore, an intravenously administered GPIIb/IIIa receptor inhibitor (tirofiban) or P2Y12 receptor blocker (cangrelor) with fast onset and offset of actions will provide more desired antiplatelet effects in the setting of PCI. This study will measure and compare the anti-platelet effects of Tirofiban and Cangrelor in patients presenting with N-STEMI and undergoing PCI.

Condition or disease Intervention/treatment
Non-ST Elevation Myocardial Infarction (NSTEMI) Drug: Tirofiban Drug: Cangrelor

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Pharmacodynamic Effects of Tirofiban vs. Cangrelor in N-STEMI Patients Undergoing Percutaneous Coronary Intervention
Actual Study Start Date : August 23, 2017
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : May 29, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Tirofiban Therapy Drug: Tirofiban
Patients will receive Tirofiban during the PCI procedure

Cangrelor Therapy Drug: Cangrelor
Patients will receive Cangrelor during the PCI procedure




Primary Outcome Measures :
  1. Assessment of platelet aggregation in response to thrombin receptor activator peptide (TRAP) at baseline and serially following tirofiban or cangrelor infusion. [ Time Frame: 24 hrs ]

Secondary Outcome Measures :
  1. Assessment of platelet aggregation in response to ADP and collagen at baseline and serially following tirofiban or cangrelor infusion. [ Time Frame: 24 hrs ]
  2. Assessment of platelet aggregation (ADP-induced) and thrombin induced platelet-fibrin clot strength by Thrombelastography (TEG6S) [ Time Frame: 24 hrs ]
  3. Assessment of thrombin generation by Calibrated Automated Thrombogram (CAT). [ Time Frame: 24 hrs ]
  4. Assessment of annexin binding and p-selectin expression by flow cytometry [ Time Frame: 24 hrs ]
  5. Real time evaluation of shear-induced thrombus formation using novel RUO T-TAS plus system. [ Time Frame: 24 hrs ]
  6. Assessment of High-Sensitivity Troponin biomarker [ Time Frame: 24 hrs ]
  7. Assessment of CK-MB biomarker [ Time Frame: 24 hr ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will consist of NSTEMI patients undergoing percutaneous coronary intervention (PCI): 30 patients each will be treated with tirofiban or cangrelor (total n=60).
Criteria

Inclusion Criteria:

1. NSTEMI meeting the following 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:

  1. Unstable angina, STEMI
  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

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): NCT03048019


Contacts
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Contact: Kevin Bliden, BS, MBA 703-776-7702 kevin.bliden@inova.org

Locations
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United States, Virginia
Inova Health Care System Recruiting
Falls Church, Virginia, United States, 22042
Contact: Kevin Bliden, BS, MBA    703-776-7702    kevin.bliden@inova.org   
Sponsors and Collaborators
Inova Health Care Services

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Responsible Party: Inova Health Care Services
ClinicalTrials.gov Identifier: NCT03048019     History of Changes
Other Study ID Numbers: 17-2617
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cangrelor
Myocardial Infarction
Non-ST Elevated Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Tirofiban
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs