Back to resultsPlatelet Aggregation in Diabetic Patients With Acute Coronary Syndrome Treated With Different Doses of Aspirin (DIABE-ASACS)
Primary Purpose
Acute Coronary Syndrome, Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
aspirin 100 mg bis in die
aspririn 200 mg once daily
aspirin 100 mg once daily
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring platelet aggregation, acute coronary syndrome, diabetes
Eligibility Criteria
Inclusion Criteria:
- Diabetic patients with acute coronary syndrome after 24 hours from the coronarography
Exclusion Criteria:
- patients with a family or personal history of bleeding or thrombophilic disorders;
- platelet count >600000/mmc or <150000/mmc
- hematocrit >50% or <25%
- creatinine clearance <30 mL/min
Sites / Locations
- Azienda Ospedaliera Universitaria Federico II
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
aspirin 100 mg bis in die
aspirin 200 mg
aspririn 100 mg
Arm Description
aspirin 100 mg twice daily for the first month after acute coronary syndrome
aspirin 200 mg once daily for the first month after acute coronary syndrome
aspirin 100 mg once daily
Outcomes
Primary Outcome Measures
Effects of different doses of aspirin on platelet aggregation
Valuation of different doses of aspirin once or twice daily on platelet aggregation after 10 day and 30 day from the acute coronary syndrome
Secondary Outcome Measures
Valuation of RAC1 levels in platelets
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05293808
Brief Title
Platelet Aggregation in Diabetic Patients With Acute Coronary Syndrome Treated With Different Doses of Aspirin
Acronym
DIABE-ASACS
Official Title
Evaluation of Different Doses of Aspirin on Platelet Aggregation in Diabetic Patients With Acute Coronary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2014 (Actual)
Primary Completion Date
October 1, 2014 (Actual)
Study Completion Date
January 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Diabetes is an important risk factor of coronary atherosclerosis, and it's well known that platelets of diabetic patients are hyper reactive and so resistant to common antithrombotic therapy. Moreover, in diabetic patients platelets are characterized by high turnover that is responsible of lack of protection by cardioaspirin at common dosage. The aim of our study is to asses the efficacy of different doses of aspirin in diabetic patients with acute coronary syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Diabetes Mellitus
Keywords
platelet aggregation, acute coronary syndrome, diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
aspirin 100 mg bis in die
Arm Type
Experimental
Arm Description
aspirin 100 mg twice daily for the first month after acute coronary syndrome
Arm Title
aspirin 200 mg
Arm Type
Active Comparator
Arm Description
aspirin 200 mg once daily for the first month after acute coronary syndrome
Arm Title
aspririn 100 mg
Arm Type
Active Comparator
Arm Description
aspirin 100 mg once daily
Intervention Type
Drug
Intervention Name(s)
aspirin 100 mg bis in die
Intervention Description
Patient will be randomized and after 10 days and 30 days we will measure platelets aggregation.
Intervention Type
Drug
Intervention Name(s)
aspririn 200 mg once daily
Intervention Description
Patient will be randomized and after 10 days and 30 days we will measure platelets aggregation.
Intervention Type
Drug
Intervention Name(s)
aspirin 100 mg once daily
Intervention Description
Patient will be randomized and after 10 days and 30 days we will measure platelets aggregation.
Primary Outcome Measure Information:
Title
Effects of different doses of aspirin on platelet aggregation
Description
Valuation of different doses of aspirin once or twice daily on platelet aggregation after 10 day and 30 day from the acute coronary syndrome
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Valuation of RAC1 levels in platelets
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diabetic patients with acute coronary syndrome after 24 hours from the coronarography
Exclusion Criteria:
patients with a family or personal history of bleeding or thrombophilic disorders;
platelet count >600000/mmc or <150000/mmc
hematocrit >50% or <25%
creatinine clearance <30 mL/min
Facility Information:
Facility Name
Azienda Ospedaliera Universitaria Federico II
City
Naples
ZIP/Postal Code
80131
Country
Italy
12. IPD Sharing Statement
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Platelet Aggregation in Diabetic Patients With Acute Coronary Syndrome Treated With Different Doses of Aspirin
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