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Effects of aspirin on markers of inflammation and coagulation in subclinical atherosclerosis in type 2 diabetic subjects.


- candidate number1536
- NTR NumberNTR305
- ISRCTNISRCTN84139732
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR11-sep-2005
- Secondary IDsP03-154 
- Public TitleEffects of aspirin on markers of inflammation and coagulation in subclinical atherosclerosis in type 2 diabetic subjects.
- Scientific TitleEffects of aspirin on markers of inflammation and coagulation in subclinical atherosclerosis in type 2 diabetic subjects.
- ACRONYMDIASP study
- hypothesisAn early intervention with low-dose aspirin in asymptomatic diabetic subjects attenuates progression of atherosclerosis, by decreasing inflammation and coagulation.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II)
- Inclusion criteria1. Diabetes mellitus type 2;
2. Age >18 year;
3. HbA1c < 10%;
4. HsCRP >1.0 mg/l .
- Exclusion criteria1. History of myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, proven manifest coronary artery disease, angina pectoris, heart failure or severe cardiac arrhythmia;
2. History of cerebrovascular accident, transient ischemic attack;
3. History of peripheral vascular disease, ankle/arm index < 1.0, history of partial ileal bypass surgery;
4. Uncontrolled hypertension;
5. Asthma;
6. Any bleeding disorder;
7. History of gastrointestinal tract bleeding;
8. Severe renal or hepatic dysfunction;
9. Pregnancy;
10. Recent participation in other research projects;
11. Recent blood donation;
12. Known allergy to salicylic acid;
13. Use of all NSAIDís;
14. Use of any antithrombotic medication;
15. Use of corticosteriods;
16. Use of HMG-CoA-reductaseinhibitors.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 27-apr-2005
- planned closingdate31-mrt-2006
- Target number of participants40
- InterventionsSubjects will be randomised between aspirin 100 mg and 300 mg. During the study period, each group will be followed 16 weeks. Treatment with aspirin (100 or 300 mg) or placebo for 6 weeks will be followed by a washout period of 4 weeks. After the washout period, patients will be treated by placebo when they received aspirin during the first period, and aspirin when they received placebo.
- Primary outcomeMarkers of vascular wall inflammation, represented by hsCRP and Il-6.
- Secondary outcome1. Prostaglandin production, represented by 11-dehydro-thromboxaneB2, 8-isoprostaglandineF2Š and 2,3-dinor-6-keto-prostaglandineF1Š measured in morning-urine samples;
2. Vascular wall adhesion molecules, represented by sICAM-1, p-selectin, MCSF, CD40L;
3. Coagulation markers, represented by fibrinogen, vWillebrand Factor and PAI-1 activity.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Marcel M.C. Hovens
- CONTACT for SCIENTIFIC QUERIES Marcel M.C. Hovens
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of General Internal Medicine
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC), Department of General Internal Medicine
- Publications1. J Thromb Haemost. 2007 Jul;5(7):1562-4. Epub 2007 Apr 19.
2. Diabetes Obes Metab. 2008 Aug;10(8):668-74. Epub 2007 Nov 22.
- Brief summaryThe DIASP study is a study with a prospective, randomised, placebo controlled, double blind, crossover study design, concerning the effects of aspirin (ASA) on markers of inflammation and coagulation in subclinical atherosclerosis in type 2 diabetic subjects. At random, forty patients will receive aspirin in low or intermediate dose in one period and placebo in the other period.
- Main changes (audit trail)
- RECORD11-sep-2005 - 11-nov-2008


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