Platelet reactivity in diabetic patients and the effects of different antithrombotic agents on the results of multiple platelet function tests

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 600

Inclusion Criteria

Cases
-Male and female patients with a diagnosis of Type 2 Diabetes Mellitus according to the WHO-criteria
->40 years
-willing to provide informed consent;Controls
->40 years
-willing to provide informed consent

Exclusion Criteria

Cases
- a history of coronary heart disease (either stable angina with angiographic confirmed significant coronary artery disease or an acute coronary syndrome)
- a history of cerebrovascular disease consisting of cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, and transient ischemic attack
- a history of arteriosclerotic disease necessitating medical treatment
- <=40 years or >75 years
- weight <60kg
- no Diabetes Mellitus
- atrial fibrillation
- Women who are known to be pregnant or who have given birth within the past 90 days, or who are breastfeeding.
- use of antiplatelet or antithrombotic therapy within the last 10 days (aspirin, NSAIDS, clopidogrel, prasugrel, ticlopidine, dipyridamole, acenocoumarol, fenprocoumon, argatroban, LMW) heparin
- a history of severe gastric or duodenal ulcer
- severe liver dysfunction
- use of steroid-treatment within the last 30 days
- severe renal dysfunction
- Allergy to either aspirin, clopidogrel or prasugrel.
- Patients who are unwilling and/or unable to give informed consent;
- Patients at increased risk of death from a pre-existing concurrent illness;Controls
- a history of coronary heart disease (either stable angina with angiographic confirmed significant coronary artery disease or an acute coronary syndrome)
- a history of cerebrovascular disease consisting of cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, and transient ischemic attack
- a history of arteriosclerotic disease necessitating medical treatment
- <=40 years or >75 years
- weight <60kg
- Diabetes Mellitus
- atrial fibrillation
- Women who are known to be pregnant or who have given birth within the past 90 days, or who are breastfeeding.
- use of antiplatelet or antithrombotic therapy within the last 10 days (aspirin, NSAIDS, clopidogrel, prasugrel, ticlopidine, dipyridamole, acenocoumarol, fenprocoumon, argatroban
- a history of severe gastric or duodenal ulcer
- severe liver dysfunction
- use of steroid-treatment within the last 30 days
- severe renal dysfunction
- Allergy to either aspirin, clopidogrel or prasugrel.
- Patients who cannot communicate reliably with the investigator;
- Patients who are unwilling and/or unable to give informed consent;
- Patients at increased risk of death from a pre-existing concurrent illness

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. The magnitude of baseline (or intrinsic) platelet reactivity among male and<br /><br>female T2DM patients and among male and female healthy volunteers as measured<br /><br>with multiple platelet function assays<br /><br><br /><br>2. Tthe magnitude of on-aspirin once daily platelet reactivity and on-<br /><br>aspirin twice daily platelet reactivity among male and female T2DM patients<br /><br>and among male and female healthy volunteers as measured with multiple platelet<br /><br>function assays<br /><br><br /><br>3. The magnitude of on-clopidogrel platelet reactivity and on-prasugrel<br /><br>platelet reactivity among male and female T2DM patients and among male and<br /><br>female healthy volunteers as measured with multiple platelet function assays<br /><br><br /><br>4. The magnitude of on-dual antiplatelet therapy platelet reactivity* among<br /><br>male and female T2DM patients and among male and female healthy volunteers as<br /><br>measured with multiple platelet function assays</p><br>

Secondary Outcome Measures