Trials / Withdrawn
WithdrawnNCT02121288
Adenosine-induced Myocardial Blood Flow in Peripheral Artery Disease Patients
A Randomized, Open-Label, Parallel, Multi-Center, Phase IV Study to Assess the Effect of Ticagrelor vs Clopidogrel on Adenosine-Induced Myocardial Blood Flow in Peripheral Artery Disease (PAD)Patients
- Status
- Withdrawn
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 59 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to assess the effect of blood flow to the heart when subjects are treated with ticagrelor (Brilinta) or clopidogrel (antiplatelet drugs that stop the blood from clumping together) in patients with Peripheral Artery Disease (PAD).
Detailed description
The effects of ticagrelor and clopidogrel on adenosine-induced myocardial blood flow (MBF) will be evaluated by cardiac 13N- ammonia positron emission tomography (PET) at rest (baseline), acute dosing on Day 1, and at short term dosing on Day 7. Subjects receiving ticagrelor will have additional pharmacokinetic (PK) blood samples collected at specific time points to measure ticagrelor concentration in the blood. Subjects' participation will be approximatetly 6 weeks.
Conditions
- Peripheral Artery Disease
- Vascular Disease
- Arterial Occlusion Disease
- Intermittent Claudication
- Ankle Brachial Index (0.9 or Less)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ticagrelor | Day 1: Loading dose of ticagrelor 180mg (two 90mg tablets) followed by 90mg dose at 12 hours after loading dose. Subject continues to take ticagrelor 90mg twice a day (morning and evening) for 7 days until next visit (Day 7). |
| DRUG | clopidogrel | Day 1: Clopidogrel 75mg oral tablet. Subjects will continue to take clopidogrel 75mg once a day for 7 days until next visit (Day 7/Visit 3). Note: no loading dose is given for the clopidogrel as those subjects are already on chronic dosing. |
Timeline
- Start date
- 2014-12-01
- Primary completion
- 2016-02-01
- Completion
- 2016-02-01
- First posted
- 2014-04-23
- Last updated
- 2014-10-15
Source: ClinicalTrials.gov record NCT02121288. Inclusion in this directory is not an endorsement.