Antithrombotic Effects of Ticagrelor Versus Clopidogrel

NCT01642238 | Completed Phase 4 Results

• 2 other identifiers: GCO 12-0732ISSBRIL0067
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Acute Coronary Syndrome

Keywords

Antiplatelet; ticagrelor; clopidogrel; bivalirudin; thrombosis

Outcome Measures

Primary Outcomes (2)

• Platelet-thrombus Formation in an ex Vivo Model of Thrombosis

  Change in thrombus size at 1 hour as compared to Pre-treatment baseline, where a positive change represents a decrease in thrombus size.

  Pre-treatment baseline and 1 hour

• Platelet-thrombus Formation in an ex Vivo Model of Thrombosis

  Change in thrombus size at 24 hours as compared to Pre-treatment baseline, where a positive change represents a decrease in thrombus size.

  Pre-treatment baseline and 24 hrs post treatment

Secondary Outcomes (6)

• Platelet Reactivity

  Pre-treatment baseline

• Platelet Reactivity

  1 hr post-treatment

• Platelet Reactivity

  24-hours post-treatment

• Blood Thrombogenicity

  Pre-treatment baseline

• Blood Thrombogenicity

  1 hr post-treatment

Study Arms (2)

Ticagrelor + ASA + Bivalirudin

EXPERIMENTAL

Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Drug: Ticagrelor + ASA + Bivalirudin

Clopidogrel + ASA + Bivalirudin

ACTIVE COMPARATOR

Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Drug: Clopidogrel + ASA + Bivalirudin

Interventions

Ticagrelor + ASA + Bivalirudin DRUG

Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Also known as: Brilinta (ticagrelor, Aspirin (ASA), Angiomax (bivalirudin)

Ticagrelor + ASA + Bivalirudin

Clopidogrel + ASA + Bivalirudin DRUG

Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Also known as: Plavix (clopidogrel), Aspirin (ASA), Angiomax (bivalirudin)

Clopidogrel + ASA + Bivalirudin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 physician.
• 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.

Sponsors & Collaborators

• Juan J Badimon: lead
• AstraZeneca: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• Zafar MU, Vorchheimer DA, Tewar MP, Giannarelli C, Crippa M, Sartori S, Rodriguez D, Baber U, Mehran R, Badimon JJ. Ticagrelor reduces thrombus formation more than clopidogrel, even when co-administered with bivalirudin. Thromb Haemost. 2014 Nov;112(5):1069-70. doi: 10.1160/TH14-03-0269. Epub 2014 Aug 7. No abstract available.

  PMID: 25104302 RESULT

MeSH Terms

Conditions

Acute Coronary Syndrome; Thrombosis

Interventions

Ticagrelor; bivalirudin; Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Juan J. Badimon
• Organization: Icahn School of Medicine at Mount Sinai

Juan.Badimon@mssm.edu

(212) 241-8484

Study Officials

• Juan J Badimon, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, AtheroThrombosis Research Unit

Study Record Dates

• First Submitted: July 13, 2012
• First Posted: July 17, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 11, 2016
• Results First Posted: July 11, 2016

Record last verified: 2016-06

Locations

US (1)