Completed

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

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What is being tested

Prasugrel 100mg loading dose

+ Prasugrel 60mg loading dose

Drug
Who is being recruted

Cardiovascular Diseases+8

+ Heart Diseases

+ Infarction

From 18 to 74 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: June 2012
See protocol details

Summary

Principal SponsorUniversity of Patras
Last updated: September 23, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01835353
Principal SponsorUniversity of Patras
Last updated: September 23, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

82 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 74 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesInfarctionIschemiaMyocardial InfarctionNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesMyocardial IschemiaST Elevation Myocardial Infarction

Criteria

4 inclusion criteria required to participate
Age > 18 and < 75 years
Pain onset < 12 hours
ST elevation myocardial infarction
Written informed consent
10 exclusion criteria prevent from participating
active bleeding
creatinine clearance < 30 ml/min
hematocrit < 30%
hemodynamic instability
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Prasugrel 100mg loading dose

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Dimitrios Alexopoulos

Pátrai, GreeceOpen Dimitrios Alexopoulos in Google Maps
CompletedOne Study Center