Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Post Percutaneous Coronary Intervention (PCI).

Phase 3 Study of Prasugrel vs High Dose (150 mg) Clopidogrel in Clopidogrel Resistant Patients Post Coronary Angioplasty.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01109784

Enrollment

Registered

2010-04-23

Start date

2010-04-30

Completion date

2010-07-31

Last updated

2010-08-24

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

Conditions

Acute Coronary Syndrome (ACS), Coronary Artery Disease (CAD)

Keywords

coronary angioplasty, clopidogrel resistance, prasugrel

Brief summary

The use of dual antiplatelet therapy is considered standard of care in patients post percutaneous coronary intervention (PCI) with stenting. However, a significant proportion of patients is considered clopidogrel resistant and this resistance is shown to be accompanied by future adverse events. Additionally, clopidogrel resistance has been linked with the CYP2C19 polymorphism. The hypothesis of the study is to define in consecutive patients undergoing PCI those that are clopidogrel resistant PCI following routinely used loading as estimated predischarge with the VerifyNow point of care system of platelet reactivity. Clopidogrel resistant patients will be randomized in 1:1 fashion to prasugrel 10 mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at day 30, when treatment crossover will be performed. At day 60 platelet reactivity will be determined as well. In addition, in all patients genetic determination of CYP polymorphisms (including the CYP2C19)known to affect clopidogrel metabolism will be performed.

Interventions

DRUGprasugrel

prasugrel 10 mg/day

DRUGclopidogrel

clopidogrel per os 150mg/day

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Age ≥18 years old * Patients having PCI with stenting 24-48 hours prior randomization, for 1. Stable angina 2.Ischaemia in provocative test 3.Acute coronary syndrome (unstable angina or myocardial infarction) * Written Informed consent * Platelet reactivity units (PRU) (VerifyNow) \>230

Exclusion criteria

* A history of bleeding diathesis * Chronic oral anticoagulation treatment * Contraindications to antiplatelet therapy * Known platelet function disorders * PCI or coronary artery bypass surgery \< 3 months * Unsuccessful PCI (residual stenosis \> 30% or flow \< Thrombolysis in myocardial infarction flow 3) * Planned staged PCI in the next 60 days * Hemodynamic instability * Cancer or hemodialysis * Platelet count \<100 000/ μL, hematocrit \<30% * Creatinine clearance \<25 ml/min * A life expectancy\<1 year, inability to give informed consent * High likelihood of being unavailable for the Day 60 follow up

Design outcomes

Primary

Measure	Time frame
Platelet Reactivity Units (PRU) assessed by VerifyNow P2Y12(Accumetrics)	Day 60

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026