NCT01531114

Brief Summary

Dual antiplatelet therapy is essential in patients following ST-Elevation myocardial infarction (STEMI) with percutaneous coronary intervention (PCI) and drug eluting stent implantation. Current guidelines recommend prasugrel and ticagrelor in patients with STEMI undergoing primary PPCI. We sought to investigate the superiority antiplatelet effect in terms of PR level of loading dose (LD) of Prasugrel (60 mg) versus LD of Ticagrelor (180 mg) in diabetic patients with STEMI undergoing primary PCI at 1 and 2 hours post drug administration. Secondary end-points will be: PR level measured at 6 and 12 hours post study drugs administrationin hospital. All consecutive diabetic patients with STEMI undergoing PPCI with stent implantation will be considered for PR assessment at 1-2-6-12 h after the drug LD administration. All patients must will be naïve for platelet P2Y12 receptor inhibition therapy. A subanalysis will be performed between two study groups according to insulin treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 10, 2012

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

June 28, 2017

Status Verified

June 1, 2017

Enrollment Period

2.2 years

First QC Date

February 7, 2012

Last Update Submit

June 27, 2017

Conditions

ST-Elevation Myocardial Infarction

Keywords

Diabetes mellitusantiplatelet effectprasugrelticagrelorSTEMIInsulin

Outcome Measures

Primary Outcomes (1)

  • the superiority antiplatelet effect in terms of PR level of loading dose (LD) of Prasugrel (60 mg) versus LD of Ticagrelor (180 mg) in diabetic patients with STEMI undergoing primary PCI at 2 hours post drug administration.

    1 and 2 hours

Secondary Outcomes (1)

  • PR level measured at 6 and 12 hours post study drugs administration.

    in hospital

Study Arms (2)

Prasugrel loading dose

ACTIVE COMPARATOR

Patients will be randomized to this arm to receive loading dose of prasugrel

Drug: ticagrelorDrug: prasugrel

ticagrelor loading dose

NO INTERVENTION

Patients will be randomized to this arm to receive loading dose of ticagrelor

Interventions

ticagrelorDRUG

Patients will be randomized to this arm to receive loading dose of ticagrelor

Prasugrel loading dose
prasugrelDRUG

Patients will be randomized to this arm to receive loading dose of prasugrel

Prasugrel loading dose

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetic patients
  • acute coronary syndrome
  • patients underwent to primary PCI
  • naïve for platelet P2Y12 receptor inhibition therapy

You may not qualify if:

  • history of bleeding diathesis
  • chronic oral anticoagulation treatment
  • contraindications to antiplatelet therapy
  • PCI or coronary artery bypass grafting (CABG) \< 3 months
  • hemodynamic instability
  • platelet count \< 100,000/μl
  • hematocrit \< 30%
  • creatinine clearance \< 25 ml/min
  • Patients with a history of stroke
  • contraindication for prasugrel administration
  • patients weighing \< 60 kg
  • patients treated with morphine
  • \> 75 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept.of Cardiovascular Sciences,Policlinico Umberto I

Rome, 00161, Italy

Location

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionDiabetes MellitusInsulin Resistance

Interventions

TicagrelorPrasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesThiophenesSulfur CompoundsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor in Cardiology

Study Record Dates

First Submitted

February 7, 2012

First Posted

February 10, 2012

Study Start

May 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

June 28, 2017

Record last verified: 2017-06

Locations

IT(1)