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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01531114
Other study ID # RESET 2D Trial
Secondary ID
Status Completed
Phase Phase 3
First received February 7, 2012
Last updated June 27, 2017
Start date May 2013
Est. completion date July 2015

Study information

Verified date June 2017
Source University of Roma La Sapienza
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Italy Dept.of Cardiovascular Sciences,Policlinico Umberto I Rome

Sponsors (1)

Lead Sponsor Collaborator
Gennaro Sardella

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 PR level measured at 6 and 12 hours post study drugs administration. in hospital
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