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The Effect of Clopidogrel and Ticagrelor With and Without Acetylsalicylic Acid (ASA) on Hemostatic System Activation at the Site of Plug Formation in Vivo in Man

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ClinicalTrials.gov Identifier: NCT02120092
Recruitment Status : Completed
First Posted : April 22, 2014
Last Update Posted : April 22, 2014
Sponsor:
Information provided by (Responsible Party):
Sabine Eichinger, Medical University of Vienna

Brief Summary:

Background: Coronary heart disease is the most common cause of death in industrialized countries. Revascularisation by percutaneous coronary angioplasty or thrombolysis is the main principle for treatment of the acute coronary syndrome. To inhibit platelet activity patients are routinely given acetylsalicylic acid (ASA) and clopidogrel, a second-generation thienopyridine. Recently, ticagrelor, a novel cyclopentyl-triazolo-pyrimidine with several pharmacological advantages, has demonstrated greater efficacy but a higher bleeding risk than clopidogrel. Coronary thrombus formation is a complex process and the antithrombotic mechanisms of platelet function inhibitors are incompletely understood. Studies in venous blood or in vitro do not truly reflect the in vivo circumstances as they often do not take into account flow conditions or the interaction between endothelium, blood cells and coagulation factors. Results from animal models may not be relevant for the prothrombotic mechanisms in humans. We have developed a technique that allows investigating hemostatic system activation directly at the site of thrombus formation in vivo in humans.

Aim: to compare the inhibitory effects of clopidogrel and ticagrelor (with and without concomitant ASA) on hemostatic system activation under circumstances close to the in vivo situation.

Design, patients and interventions: prospective, randomized, double-blind, placebo controlled parallel-group study with a 2x2 factorial design including 112 healthy volunteers who will be randomised to 4 treatment arms: ticagrelor or clopidogrel + placebo, ticagrelor or clopidogrel + ASA.

Outcome variables: Indicators of platelet and coagulation activation [ß-thromboglobulin and thromboxane B2 as well as prothrombin fragment F1+2 and D-Dimer, respectively] will be measured before and at several time points during a 8 day period in venous blood and in blood emerging from a standardized injury of the microvasculature to determine bleeding time (shed blood).

Statistical considerations: Sample size calculation is based on the percent change in the main outcome variable "β-TG in shed blood" from baseline to 2 hours after treatment start. Statistical analysis is based on the full analysis set, including all randomized subjects who received at least the starting dose of the study medication and for whom blood collections at baseline and at 2 hours after treatment start have been performed.


Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: Clopidogrel Drug: Ticagrelor Drug: ASA Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Clopidogrel and Ticagrelor With and Without Acetylsalicylic Acid (ASA) on Hemostatic System Activation at the Site of Plug Formation in Vivo in Man
Study Start Date : October 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Clopidogrel + ASA Drug: Clopidogrel
1x Loading dose 600 mg 6x maintenance dose 150 mg

Drug: ASA

7x 100mg acetylsalicylic acid (clopidogrel arm)

1x 300 mg acetylsalicylic acid (ticagrelor arm)


Placebo Comparator: Clopidogrel + Placebo Drug: Clopidogrel
1x Loading dose 600 mg 6x maintenance dose 150 mg

Drug: Placebo
7x 300mg acetylsalicylic acid placebo

Active Comparator: Ticagrelor + ASA Drug: Ticagrelor
1x Loading dose: 180 mg 6x Maintenance dose: 90 mg bid

Drug: ASA

7x 100mg acetylsalicylic acid (clopidogrel arm)

1x 300 mg acetylsalicylic acid (ticagrelor arm)


Placebo Comparator: Ticagrelor + Placebo Drug: Ticagrelor
1x Loading dose: 180 mg 6x Maintenance dose: 90 mg bid

Drug: Placebo
7x 300mg acetylsalicylic acid placebo




Primary Outcome Measures :
  1. ß-Thromboglobulin in shed blood 2h after first study drug intake [ Time Frame: 2 hours after first study drug intake ]


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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • young, healthy males

Exclusion Criteria:

  • history of bleeding
  • any medication
  • known intolerance to study drug(s)

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): NCT02120092


Locations
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Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Sabine Eichinger-Hasenauer, MD Medical University of Vienna

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Responsible Party: Sabine Eichinger, Ao. Univ. Prof. Sabine Eichinger, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02120092     History of Changes
Other Study ID Numbers: ClopidogrelTicagrelorASA
First Posted: April 22, 2014    Key Record Dates
Last Update Posted: April 22, 2014
Last Verified: April 2014

Keywords provided by Sabine Eichinger, Medical University of Vienna:
ACS, Acute coronary syndrome

Additional relevant MeSH terms:
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Aspirin
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Ticagrelor
Hemostatics
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Coagulants