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

February 10, 2012 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Adenosinladder; Ticagrelor (180 mg), Adenosinladder ; Theophylline (5 mg/kg), Adenosinladder
Drug: AZD6140
P2Y12 receptor antagonist
Other Names:
  • Ticagrelor
Placebo Comparator: 2
Adenosinladder; Placebo, Adenosinladder; Theophylline (5 mg/kg), Adenosinladder
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
During 6 h at visit 3

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
During 6 h at visit 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Jay Horrow, MD, AstraZeneca
  • Principal Investigator: Marianne Hartford, MD, CTC, Göteborg
  • Study Chair: Mirjana Kujacic, MD PhD, AstraZeneca, Mölndal Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

October 21, 2010

First Submitted That Met QC Criteria

October 21, 2010

First Posted (Estimate)

October 22, 2010

Study Record Updates

Last Update Posted (Estimate)

February 13, 2012

Last Update Submitted That Met QC Criteria

February 10, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5130C00067
  • 2010-021820-91 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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