Ex-Vivo Reversion of Platelet Inhibition Induced by NCT01839968

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Details — Status: Completed

The purpose of this ex-vivo study is to estimate the optimal platelet quantity necessary to reverse the antiplatelet effects of prasugrel.

Recruitment information / eligibility
Status	Completed
Enrollment	32
Est. completion date	January 2014
Est. primary completion date	December 2013
Accepts healthy volunteers	No
Gender	Both
Age group	18 Years and older
Eligibility	Inclusion Criteria: - Acute coronary syndrome - Prasugrel loading dose 6-24h before inclusion Exclusion Criteria: - Clopidogrel loading dose - GPIIbIIIa use within 10 days before inclusion - Known congenital thrombopathy and/or congenital coagulation defect

Observational Model: Case-Only, Time Perspective: Prospective

Other:
• Ex vivo addition of normal platelet rich plasma to prasugrel-treated platelet rich plasma

Locations
Country	Name	City	State
Switzerland	University Hospital of Geneva	Geneva	GE

Sponsors *(1)*
Lead Sponsor	Collaborator
University Hospital, Geneva

Switzerland,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Platelet reactivity assessed by light transmittance aggregometry (LTA) after ex-vivo normal platelet addition		within the first 6-24 hours after antiplatelet drug loading dose	No