PraSugrel vs TicagrElor in ST-Elevation Myocardial Infarction paTients With Diabetes Mellitus (RESET 2D)
Primary Purpose
ST-Elevation Myocardial Infarction
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
ticagrelor
prasugrel
Sponsored by
About this trial
This is an interventional treatment trial for ST-Elevation Myocardial Infarction focused on measuring Diabetes mellitus, antiplatelet effect, prasugrel, ticagrelor, STEMI, Insulin
Eligibility Criteria
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.
Sites / Locations
- Dept.of Cardiovascular Sciences,Policlinico Umberto I
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Prasugrel loading dose
ticagrelor loading dose
Arm Description
Patients will be randomized to this arm to receive loading dose of prasugrel
Patients will be randomized to this arm to receive loading dose of ticagrelor
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
PR level measured at 6 and 12 hours post study drugs administration.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01531114
Brief Title
PraSugrel vs TicagrElor in ST-Elevation Myocardial Infarction paTients With Diabetes Mellitus
Acronym
RESET 2D
Official Title
Prasugrel Or Ticagrelor In ST-Elevation Myocardial Infarction Patients With Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gennaro Sardella
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-Elevation Myocardial Infarction
Keywords
Diabetes mellitus, antiplatelet effect, prasugrel, ticagrelor, STEMI, Insulin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prasugrel loading dose
Arm Type
Active Comparator
Arm Description
Patients will be randomized to this arm to receive loading dose of prasugrel
Arm Title
ticagrelor loading dose
Arm Type
No Intervention
Arm Description
Patients will be randomized to this arm to receive loading dose of ticagrelor
Intervention Type
Drug
Intervention Name(s)
ticagrelor
Intervention Description
Patients will be randomized to this arm to receive loading dose of ticagrelor
Intervention Type
Drug
Intervention Name(s)
prasugrel
Intervention Description
Patients will be randomized to this arm to receive loading dose of prasugrel
Primary Outcome Measure Information:
Title
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.
Time Frame
1 and 2 hours
Secondary Outcome Measure Information:
Title
PR level measured at 6 and 12 hours post study drugs administration.
Time Frame
in hospital
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Dept.of Cardiovascular Sciences,Policlinico Umberto I
City
Rome
ZIP/Postal Code
00161
Country
Italy
12. IPD Sharing Statement
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PraSugrel vs TicagrElor in ST-Elevation Myocardial Infarction paTients With Diabetes Mellitus
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