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OpenTrials
Completed

NCT Number: NCT01226602

Study to Assess the Effect of Ticagrelor on Coronary Blood Flow in Healthy Male Subjects.

The purpose of this study is to determine if Ticagrelor increases the Adenosin induced coronary blood flow velocity.

Completed

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Key information

Conditions

Blood Flow Speed Coronary Flow Velocity

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD6140

Drug

P2Y12 receptor antagonist

Other names: Ticagrelor

Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 22, 2010
Registry last updated
Feb 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.