High (100mg) Versus Standard (60mg) Loading Dose of Prasugrel in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01835353

Enrollment

Registered

2013-04-18

Start date

2012-06-30

Completion date

2013-07-31

Last updated

2013-09-23

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

Conditions

Platelet Reactivity

Keywords

prasugrel, ST elevation myocardial infarction

Brief summary

This is a prospective, multi-center, non-randomized, controlled study in 2 sequential groups of P2Y12 inhibitor-naive consecutive STEMI patients undergoing primary PCI. Following aspirin 325 mg LD, patients will receive 60 mg or 100 mg of prasugrel, respectively. Platelet reactivity (PR)will be assessed at Hour 0 (before prasugrel's administration immediately prior to PCI) and at Hours 0.5, 1, 2, 4 thereafter. Platelet function testing (in PRU) will be performed with the VerifyNow (Accumetrics Inc., San Diego, CA, USA) P2Y12 function assay.

Interventions

DRUGPrasugrel 100mg loading dose

DRUGPrasugrel 60mg loading dose

Prasugrel 60mg loading dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 74 Years

Healthy volunteers

Inclusion criteria

* ST elevation myocardial infarction * Pain onset \<12 hours * Age \>18 and \<75 years * Written informed consent

Exclusion criteria

* history of stroke/transient ischemic attack * oral anticoagulation * hemodynamic instability * platelet count \<100000/μL * hematocrit \<30% * creatinine clearance \<30 ml/min * severe hepatic dysfunction * active bleeding * weight \<60 Kg * periprocedural IIb/IIIa inhibitor administration

Design outcomes

Primary

Measure	Time frame	Description
Platelet reactivity in Platelet reactivity units (PRU) at Hour 2	2 hours	Platelet reactivity in Platelet reactivity units (PRU) 2 hours post randomization

Secondary

Measure	Time frame	Description
Platelet reactivity in platelet reactivity units (PRU)at hour 0.5	0.5 hours	Platelet reactivity in platelet reactivity units (PRU)0.5 hour post randomization
Platelet reactivity in platelet reactivity units (PRU)at hour 4	4 hours	Platelet reactivity in platelet reactivity units (PRU)4 hours post randomization
High platelet reactivity rate (208 PRU threshold) at 0.5 hour	0.5 hour	High platelet reactivity rate (208 PRU threshold) 0.5 hour post randomization
Platelet reactivity in platelet reactivity units (PRU)at hour 1	1 hour	Platelet reactivity in platelet reactivity units (PRU)1 hour post randomization
High platelet reactivity rate (208 PRU threshold) at 2 hour	2 hours	High platelet reactivity rate (208 PRU threshold) 2 hours post randomization
High platelet reactivity rate (208 PRU threshold) at 4 hour	4 hours	High platelet reactivity rate (208 PRU threshold) 4 hours post randomization
High platelet reactivity rate (208 PRU threshold) at 1 hour	1 hour	High platelet reactivity rate (208 PRU threshold) 1 hour post randomization

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026