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

ISRCTN	ISRCTN84139732
DOI	https://doi.org/10.1186/ISRCTN84139732
Protocol serial number	NTR305; P03-154
Sponsor	Leiden University Medical Centre (LUMC) (Netherlands)
Funder	Leiden University Medical Centre (LUMC) (Netherlands) - Department of General Internal Medicine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Marcel M.C. Hovens
Scientific

Leiden University Medical Center
Department of General Internal Medicine
P.O. Box 9600
Leiden
2300 RC
Netherlands

Primary study design	Interventional
Study design	Randomised double-blind placebo controlled crossover trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	DIASP study
Study objectives	An early intervention with low-dose aspirin in asymptomatic diabetic subjects attenuates progression of atherosclerosis, by decreasing inflammation and coagulation.
Ethics approval(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	Diabetes mellitus type 2 (DM type 2)
Intervention	Subjects 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.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Aspirin
Primary outcome measure(s)	Markers of vascular wall inflammation, represented by hsCRP and IL-6
Key secondary outcome measure(s)	1. Prostaglandin production, represented by 11-dehydro-thromboxaneB2, 8-isoprostaglandineF2a and 2,3-dinor-6-keto-prostaglandineF1a 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
Completion date	31/03/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	40
Key inclusion criteria	1. Diabetes mellitus type 2 2. Aged greater than 18 years 3. HbA1c less than 10% 4. High sensitivity C-reactive protein (hsCRP) greater than 1.0 mg/l
Key exclusion criteria	1. 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 ischaemic attack 3. History of peripheral vascular disease, ankle/arm index less than 10, 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 non-steroidal anti-inflammatory drugs (NSAIDs) 14. Use of any anti-thrombotic medication 15. Use of corticosteriods 16. Use of HMG-CoA-reductase inhibitors
Date of first enrolment	27/04/2005
Date of final enrolment	31/03/2006

Leiden University Medical Center

Leiden
2300 RC
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2007		Yes	No
Results article	results	01/08/2008		Yes	No