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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
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
The purpose of this study is to determine if Ticagrelor increases the Adenosin induced coronary blood flow velocity.

Condition or disease Intervention/treatment Phase
Blood Flow Speed Coronary Flow Velocity Drug: AZD6140 Drug: Placebo Phase 1

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  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 :
  1. 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 ]
  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 ]
  3. 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 ]

Eligibility Criteria
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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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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): NCT01226602


Locations
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Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Jay Horrow, MD AstraZeneca
Principal Investigator: Marianne Hartford, MD CTC, Göteborg
Study Chair: Mirjana Kujacic, MD PhD AstraZeneca, Mölndal Sweden
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by AstraZeneca:
Ticagrelor
Healthy
Coronary flow velocity
Adenosine
Additional relevant MeSH terms:
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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