A Pharmacodynamic Study With Ticagrelor in Hispanic Patients
This study is currently recruiting participants.
Verified February 2013 by AstraZeneca
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01523366
First received: January 30, 2012
Last updated: February 4, 2013
Last verified: February 2013
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Purpose
The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in Hispanic patients with stable coronary artery disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Stable Coronary Artery Disease |
Drug: Ticagrelor Drug: Clopidogrel |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in Hispanic Patients With Stable Coronary Artery Disease |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Inhibition of the P2Y12 receptor measured by Platelet Reactivity Unit [ Time Frame: At 2 hours after the loading dose ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Inhibition of the P2Y12 receptor measured by Platelet Reactivity Unit [ Time Frame: At 0.5 and 8 hours after the loading dose ] [ Designated as safety issue: No ]
- Inhibition of the P2Y12 receptor measured by Platelet Reactivity Unit [ Time Frame: At 2, 8 and 24 hours from last dose ] [ Designated as safety issue: No ]
- Area under the plasma concentration versus time curve (AUC) of ticagrelor [ Time Frame: Predose, 0.5, 2, 8 from loading dose; 0, 2, 8 and 24 from last dose ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ticagrelor |
Drug: Ticagrelor
Min - 90mg/Max - 180mg tablets (loading dose)
|
| Active Comparator: Clopidogrel |
Drug: Clopidogrel
75mg (once daily)/Max - 600mg tablets (loading dose)
|
Detailed Description:
A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor versus Clopidogrel in Hispanic Patients with Stable Coronary Artery Disease
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Provision of signed and dated informed consent before initiation of any study-related procedures
- Male or female patients aged 18 years or older Documented stable CAD fulfilling and taking 75-100mg ASA daily treatment
- Females must be post menopausal or surgically sterile Self-identified as Hispanic
Exclusion Criteria:
- Any indication for oral anticoagulant (e.g., atrial fibrillation, mitral stenosis or prosthetic heart valve) or dual antiplatelet treatment (e.g., clopidogrel, prasugrel, ASA dose other than 75 to 100 mg daily) during study period
- Patients who had ACS or stent placed within 12 months of screening Patients with a history of moderate or severe hepatic impairment
- Current smokers, including the use of tobacco containing products in the past 1 month of randomization
- Patients requiring dialysis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523366
Contacts
| Contact: AstraZeneca Clinical Study Information | 800-236-9933 | information.center@astrazeneca.com |
Locations
| United States, California | |
| Research Site | Recruiting |
| Lajolla, California, United States | |
| Research Site | Recruiting |
| Los Angeles, California, United States | |
| United States, Florida | |
| Research Site | Recruiting |
| Hollywood, Florida, United States | |
| Research Site | Recruiting |
| Jacksonville, Florida, United States | |
| Research Site | Recruiting |
| Miami, Florida, United States | |
| United States, Maryland | |
| Research Site | Recruiting |
| Towson, Maryland, United States | |
| United States, New Jersey | |
| Research Site | Recruiting |
| Linden, New Jersey, United States | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Glenn Carlson, MD | AstraZeneca PharmaceuticalsRoom C3B-718PO Box 15437Wilmington, DE 19850-5437 USA |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01523366 History of Changes |
| Other Study ID Numbers: | D5130L00012 |
| Study First Received: | January 30, 2012 |
| Last Updated: | February 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
Stable Coronary Artery Disease, CAD |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Clopidogrel Ticagrelor Platelet Aggregation Inhibitors |
Hematologic Agents Therapeutic Uses Pharmacologic Actions Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013