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Study to Assess the Effect of Ticagrelor on Coronary Blood Flow in Healthy Male Subjects.
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01226602
First received: October 21, 2010
Last updated: February 10, 2012
Last verified: February 2012
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Purpose
The purpose of this study is to determine if Ticagrelor increases the Adenosin induced coronary blood flow velocity.
| Condition | Intervention | Phase |
|---|---|---|
| Blood Flow Speed Coronary Flow Velocity | Drug: AZD6140 Drug: Placebo | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-blind, Placebo Controlled, Crossover, Single Centre Phase I Study to Assess the Effect of Ticagrelor on Adenosine-induced Coronary Blood Flow Velocity in Healthy Male Subjects |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Assess the effect of Ticagrelor compared to placebo on the adenosine induced coronary blood flow velocity response by estimating the change in area under the adenosine dose response curve before and after study drug. [ Time Frame: During 6 h at visit 2 ]
- Assess the effect of Ticagrelor compared to placebo on the adenosine induced coronary blood flow velocity response by estimating the change in area under the adenosine dose response curve before and after study drug. [ Time Frame: During 6 h at visit 3 ]
Secondary Outcome Measures:
- Effect of Ticagrelor compared to placebo on the adenosine induced coronary blood flow velocity by estimating the change in area under the adenosine dose response curve before and after infusion of theophylline. [ Time Frame: During 6 h at visit 2 ]
- Difference in basal blood flow (in the absence of adenosine) between Ticagrelor and placebo conditions before and after infusion of theophylline. [ Time Frame: During 6h at visit 2 ]
- Difference in basal blood flow (in the absence of adenosine) between Ticagrelor and placebo conditions before and after infusion of theophylline. [ Time Frame: During 6 h at visit 3 ]
| Enrollment: | 39 |
| Study Start Date: | December 2010 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Adenosinladder; Ticagrelor (180 mg), Adenosinladder ; Theophylline (5 mg/kg), Adenosinladder
|
Drug: AZD6140
P2Y12 receptor antagonist
Other Name: Ticagrelor
|
|
Placebo Comparator: 2
Adenosinladder; Placebo, Adenosinladder; Theophylline (5 mg/kg), Adenosinladder
|
Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Suitable for ECG recording of CBFV and have no adverse reaction to adenosine challenge
- Have a body mass index between 18 and 30 kg/m2
Exclusion Criteria:
- History of clinically significant disease or disorder.
- Abnormal vital signs
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226602
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226602
Locations
| Sweden | |
| Research Site | |
| Uppsala, Sweden | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Jay Horrow, MD | AstraZeneca |
| Principal Investigator: | Marianne Hartford, MD | CTC, Göteborg |
| Study Chair: | Mirjana Kujacic, MD PhD | AstraZeneca, Mölndal Sweden |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01226602 History of Changes |
| Other Study ID Numbers: |
D5130C00067 2010-021820-91 ( EudraCT Number ) |
| Study First Received: | October 21, 2010 |
| Last Updated: | February 10, 2012 |
Keywords provided by AstraZeneca:
|
Ticagrelor Healthy Coronary flow velocity Adenosine |
Additional relevant MeSH terms:
|
Ticagrelor Adenosine Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Vasodilator Agents Purinergic P1 Receptor Agonists Purinergic Agonists |
ClinicalTrials.gov processed this record on August 21, 2017