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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01226602
Enrollment
39
Registered
2010-10-22
Start date
2010-12-31
Completion date
2011-04-30
Last updated
2012-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Flow Speed, Coronary Flow Velocity

Keywords

Ticagrelor, Healthy, Coronary flow velocity, Adenosine

Brief summary

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

Interventions

P2Y12 receptor antagonist

DRUGPlacebo

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 40 Years
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

Design outcomes

Primary

MeasureTime 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.During 6 h at visit 2

Secondary

MeasureTime 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.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.During 6h at visit 2

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026