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

Blood Flow Speed Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01226602
• Other study ID #: D5130C00067
• Secondary ID: 2010-021820-91
• Status: Completed
• Phase: Phase 1
• First received: October 21, 2010
• Last updated: February 10, 2012
• Start date: December 2010
• Est. completion date: April 2011

Study information

• Verified date: February 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Flow Speed
• Coronary Flow Velocity

Intervention

Drug:
• AZD6140
P2Y12 receptor antagonist
• Placebo

Locations

Country	Name	City	State
Sweden	Research Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		During 6 h at visit 2	No
Primary	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.		During 6 h at visit 3	No
Secondary	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.		During 6 h at visit 2	No
Secondary	Difference in basal blood flow (in the absence of adenosine) between Ticagrelor and placebo conditions before and after infusion of theophylline.		During 6h at visit 2	No
Secondary	Difference in basal blood flow (in the absence of adenosine) between Ticagrelor and placebo conditions before and after infusion of theophylline.		During 6 h at visit 3	No