PraSugrel vs TicagrElor in ST-Elevation Myocardial Infarction paTients With Diabetes Mellitus

Prasugrel Or Ticagrelor In ST-Elevation Myocardial Infarction Patients With Diabetes Mellitus

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01531114

Acronym

RESET 2D

Enrollment

Registered

2012-02-10

Start date

2013-05-31

Completion date

2015-07-31

Last updated

2017-06-28

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

Conditions

ST-Elevation Myocardial Infarction

Keywords

Diabetes mellitus, antiplatelet effect, prasugrel, ticagrelor, STEMI, Insulin

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.

Interventions

DRUGticagrelor

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

DRUGprasugrel

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
PR level measured at 6 and 12 hours post study drugs administration.	in hospital

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026