Antiplatelet Effects of Tirofiban vs. Cangrelor N-STEMI Patients Undergoing Percutaneous Coronary Intervention

December 7, 2023 updated by: Inova Health Care Services

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Tirofiban Therapy
patients randomized to tirofiban therapy
Drug: Tirofiban
Patients will receive Tirofiban during the PCI procedure
Other Names:
  • Aggrastat
Cangrelor Therapy
patients randomized to cangrelor therapy
Drug: Cangrelor
Patients will receive Cangrelor during the PCI procedure
Other Names:
  • Kengreal

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Thrombin Receptor Activator Peptide (TRAP) Induced Platelet Aggregation (%)
Time Frame: 30 minutes post-start of the infusion
Assessment of platelet aggregation (%) in response to 10uM thrombin receptor activator peptide. Normal reference range is 60-100% aggregation.
30 minutes post-start of the infusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adenosine Diphosphate (ADP) Induced Platelet Aggregation (%)
Time Frame: 30 minutes post-start of the infusion
Assessment of platelet aggregation (%) in response to 20uM ADP at baseline and serially following tirofiban or cangrelor infusion. Normal reference range is 60-100% aggregation.
30 minutes post-start of the infusion
Thrombin Induced Platelet-fibrin Clot Strength (mm)
Time Frame: 30 minutes post-start of the infusion
Assessment of thrombin induced platelet-fibrin clot strength (mm) by thromboelastography (TEG6S). Normal reference range is 55-68 mm
30 minutes post-start of the infusion
Shear-induced Thrombus Formation (AUC)
Time Frame: 30 minutes after the end of the infusion.
Real time evaluation of shear-induced thrombus formation using novel RUO T-TAS plus system. AUC is calculated as time to reach 60 kPa
30 minutes after the end of the infusion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inova Health Care Services

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paul Gurbel, MD, Inova Health Care Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 23, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 27, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 27, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2017

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-2617

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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