Study to Assess the Effect of Ticagrelor on Coronary Blood Flow in Healthy Male Subjects.
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ClinicalTrials.gov Identifier: NCT01226602 |
Recruitment Status :
Completed
First Posted : October 22, 2010
Last Update Posted : February 13, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Blood Flow Speed Coronary Flow Velocity | Drug: AZD6140 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 39 participants |
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 |
Study Start Date : | December 2010 |
Actual Primary Completion Date : | April 2011 |
Actual Study Completion Date : | April 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Adenosinladder; Ticagrelor (180 mg), Adenosinladder ; Theophylline (5 mg/kg), Adenosinladder
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Drug: AZD6140
P2Y12 receptor antagonist
Other Name: Ticagrelor |
Placebo Comparator: 2
Adenosinladder; Placebo, Adenosinladder; Theophylline (5 mg/kg), Adenosinladder
|
Drug: Placebo |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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

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): NCT01226602
Sweden | |
Research Site | |
Uppsala, Sweden |
Study Director: | Jay Horrow, MD | AstraZeneca | |
Principal Investigator: | Marianne Hartford, MD | CTC, Göteborg | |
Study Chair: | Mirjana Kujacic, MD PhD | AstraZeneca, Mölndal Sweden |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT01226602 |
Other Study ID Numbers: |
D5130C00067 2010-021820-91 ( EudraCT Number ) |
First Posted: | October 22, 2010 Key Record Dates |
Last Update Posted: | February 13, 2012 |
Last Verified: | February 2012 |
Ticagrelor Healthy Coronary flow velocity Adenosine |
Ticagrelor 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 |