CompletedPhase 3Phase 4ACTRN12612001157864

The effect of the antiplatelet drug Prasugrel on the interactions between immune cells and the blood clotting cells platelets in patients with cardiovascular disease.

The effect of Prasugrel on Platelet – Lymphocyte Interactions in Vascular disease

Sponsor

Capital and Coast District Heath Board

Enrollment

24 participants

Start Date

Jun 24, 2013

Study Type

Interventional

Conditions

Atherosclerosis

Summary

The purpose of this research study is to investigate the effects of Prasugrel (a drug that makes your platelets less sticky) against a placebo (no medication but still a tablet). We want to see how Prasugrel affects the way the blood clotting cells platelets, interact with immune cells in the blood. The disease that causes the narrowing of arteries is driven by immune cells and it could be important to see how inhibiting platelets affects these immune cells and potentially decrease the narrowing of arteries

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria7

Vascular population
Patients on carotid surveillance programme with an identified carotid stenosis
of >50%
Patient is not on any antiplatelet therapy
Healthy population
Healthy volunteers aged 18-45
Not on any cardiovascular medication or immune modulating drugs.

Exclusion Criteria10

Acute coronary syndrome within the preceding 3 months.
Intercurrent illness
Inability to provide written informed consent.
Compliance with follow-up likely to be inadequate
Known bleeding disorder
Platelet dysfunction
Recent surgery within 3 months
Pregnancy
Allergy to Prasugrel
Administration of antiplatelet agent of NSAIDs in last 2 weeks

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Interventions

This study is a randomised crossover trial and patients with vascular disease and healthy volunteers will receive both Prasugrel and Placebo in oral capsule form. A single loading dose of 60mg of Prasugrel will be given on day 1 and then 10mg per day maintenance for 6 days. Placebo will also be administered for 7 days as a separate drug treatment. There will be a wash out period of 3 weeks between the two treatment periods.