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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00649909
Other study ID # 0020-08-HMO-CTIL
Secondary ID
Status Completed
Phase N/A
First received March 27, 2008
Last updated August 9, 2017
Start date November 2008
Est. completion date November 2010

Study information

Verified date August 2017
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The efficacy of low dose aspirin appears to be substantially lower in diabetic patients, compared to patients without diabetes.

We will perform an observational study where we follow up patients with uncontrolled type 2 Diabetes Mellitus and low response to aspirin (Aspirin Resistance), during a period of 6 months in the diabetic clinic. Our hypothesis is that glucose control will improve the response to aspirin in those patients.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria

1. Type 2 DM.

2. Patients that take aspirin.

3. Antecubital forearm veins allowing technically good sampling for platelet studies.

4. Reduced Laboratory response to aspirin.

5. HbA1c > 8 %

6. The physician decides that there is an indication for glucose control.

Exclusion Criteria:

1. Acute ischemic stroke, acute coronary syndrome, (myocardial infarction or unstable angina pectoris), or revascularization by PCI or by-pass surgery within the last 6 months.

2. Acute kidney disease or chronic kidney disease with creatinine clearance <30.

3. Acute liver disease or chronic liver disease with severe liver impairment.

4. Need for treatment with anticoagulants, clopidogrel, NSAID's, or thiazolidinediones.

5. Thrombocytopenia (platelet count <150 x 109/L)

Study Design


Locations

Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary The outcome measure is the laboratory Aspirin Resistance. 3 and 6 months.
Secondary To determine the incidence of laboratory aspirin resistance in type 2 DM in stable out-patients in the diabetic clinic, and possibly related factors. On screening visit.
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