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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612001157864

Enrollment

Registered

2012-10-31

Start date

2013-06-24

Completion date

2013-10-07

Last updated

2020-01-13

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

Conditions

None listed

Brief 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

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

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

Outcome results