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Antithrombotic Effects of Ticagrelor Versus Clopidogrel

Information source: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Coronary Syndrome

Intervention: Ticagrelor + ASA + Bivalirudin (Drug); Clopidogrel + ASA + Bivalirudin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Juan J Badimon

Official(s) and/or principal investigator(s):
Juan J Badimon, PhD, Principal Investigator, Affiliation: Icahn School of Medicine at Mount Sinai


The purpose of this study is to determine whether treatment with ticagrelor (plus aspirin and bivalirudin) is more effective than treatment with clopidogrel (plus aspirin and bivalirudin).

Clinical Details

Official title: Randomized, Crossover Study of the Antithrombotic Effects of Ticagrelor Plus Aspirin Versus Clopidogrel Plus Aspirin When Administered With Bivalirudin

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Platelet-thrombus formation in an ex vivo model of thrombosis

Platelet-thrombus formation in an ex vivo model of thrombosis

Platelet-thrombus formation in an ex vivo model of thrombosis

Secondary outcome:

Platelet reactivity by Accumetrics VerifyNow and Multiplate Analyzer

Platelet reactivity by Accumetrics VerifyNow and Multiplate Analyzer

Platelet reactivity by Accumetrics VerifyNow and Multiplate Analyzer

Blood thrombogenicity by Thromboelastography

Blood thrombogenicity by Thromboelastography

Blood thrombogenicity by Thromboelastography

Detailed description: The HORIZONS-AMI Trial compared the effectiveness of heparin plus a glycoprotein IIb/IIIa inhibitor (GPI) versus bivalirudin in acute myocardial infarction (AMI) patients undergoing stent deployment 1. Overall the data showed benefits associated with the bivalirudin treatment with lower rates of all-cause mortality, cardiac mortality, re-infarction and non-CABG related major bleeding; However, the data seems to indicate a non-significant increase in acute stent thrombosis in the bivalirudin group. This observation seems to suggest the potential benefits of adding an antiplatelet agent to bivalirudin. A study by Dangas G et al found that in the HORIZONS-AMI patients, the group receiving 600 mg loading-dose of clopidogrel had significantly lower 30-day unadjusted rates of mortality, reinfarction and stent thrombosis than the 300 mg loading-dose group, without increase in bleeding rate. Furthermore, even though the benefits of bivalirudin were independent of the clopidogrel loading dose; the 600mg LD was associated with more benefits with both anticoagulation regimens. Similar observations have been reported in the ARMYDA-6 MI study. It is our hypothesis that using ticagrelor instead of clopidogrel, given its more potent and faster activity, would have greater antithrombotic activity and therefore may reduce the rate of acute stent thrombosis when administered in combination with bivalirudin + ASA in AMI patients. To investigate this hypothesis, we will compare the antithrombotic effects of ticagrelor with clopidogrel, when administered in combination with ASA and bivalirudin, in healthy human volunteers using a cross-over study design. The antithrombotic activity will be assessed pre-treatment and 2-hours and 24-hours post treatment, using methodologies including Badimon Perfusion chamber, VerifyNow P2Y12 assay, platelet aggregation with Multiplate Analyzer and Thromboelastography.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- Male or female volunteers between 18 and 65 years old.

- Body mass index (BMI) 18 - 30 kg/m2 inclusive.

- Healthy as assessed by a detailed medical history and physical examination.

- Laboratory est results within the normal range.

- Ability to provide signed informed consent.

Exclusion Criteria:

- History of clinically relevant disease, bleeding, acute infectious disease or signs

of acute illness.

- Allergy or hypersensitivity to aspirin or thienopyridines, or atopy diagnosed by a


- Use of medication within one month prior to study drug administration.

- History of drug abuse or alcohol consumption >20 g/day.

- Inability to abstain from intensive muscular effort or sport competition.

- Loss of >400 mL blood or blood donation within 3 months.

- Positive serology for hepatitis B (HBs Ag) or hepatitis C.

- Conditions associated with hemorrhagic risk.

- Positive pregnancy test.

Locations and Contacts

Icahn School of Medicine at Mount Sinai, New York, New York 10029, United States
Additional Information

Starting date: July 2012
Last updated: January 16, 2014

Page last updated: August 23, 2015

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