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
| Tracking Information | |||||
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| First Received Date ICMJE | January 30, 2012 | ||||
| Last Updated Date | February 4, 2013 | ||||
| Start Date ICMJE | April 2012 | ||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Inhibition of the P2Y12 receptor measured by Platelet Reactivity Unit [ Time Frame: At 2 hours after the loading dose ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01523366 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Pharmacodynamic Study With Ticagrelor in Hispanic Patients | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in Hispanic patients with stable coronary artery disease. |
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| 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 |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Stable Coronary Artery Disease | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | October 2013 | ||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01523366 | ||||
| Other Study ID Numbers ICMJE | D5130L00012 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | AstraZeneca | ||||
| Study Sponsor ICMJE | AstraZeneca | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | AstraZeneca | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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