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| [ ...Back to search results ] | [ Print-friendly version ] |
| Impact of single versus double dose acetylsalicylic acid on platelet function in patients with type 2 diabetes |
| ISRCTN | ISRCTN34087526 |
| ClinicalTrials.gov identifier | |
| Public title | Impact of single versus double dose acetylsalicylic acid on platelet function in patients with type 2 diabetes |
| Scientific title | Impact of single versus double dose acetylsalicylic acid on platelet function in patients with type 2 diabetes: a randomised crossover study |
| Acronym | ASP |
| Serial number at source | 10708 |
| Study hypothesis |
The high residual platelet reactivity commonly seen in aspirin-treated patients with type 2 diabetes mellitus might be overcome by giving higher or more frequent doses of aspirin. The study will evaluate the impact of single, double or twice daily dosing regimens on platelet function in patients with type 2 diabetes mellitus who do not have cardiovascular disease.
More details can be found at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=10708 |
| Lay summary | Lay summary under review |
| Ethics approval | South East London Research Ethics Committee 3 First MREC approval date 07/09/2011, 11/LO/1200 |
| Study design | Randomised; Interventional; Design type: Treatment |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Diabetes (type 2) |
| Participants - inclusion criteria |
1. Have type 2 diabetes (defined according to the European Association for the Study of Diabetes (EASD) guidelines)
2. Are aged >18 years and <55 years 3. Have not had a coronary event or other indication requiring ASA 4. Are on diet alone or stable doses of antihyperglycaemic medication, i.e. the type of medication or dose used has not been changed for at least 3 months 5. Have HbA1c levels ≤ 8.0% 6. Have triglycerides ≤ 2mmol/l; Target Gender: Male & Female; Upper Age Limit 54 years ; Lower Age Limit 18 years |
| Participants - exclusion criteria |
1. Have cardiovascular disease, including coronary heart disease, stroke and peripheral artery disease
2. Have been taking any dose of ASA, non-steroidal anti-inflammatory drugs, any antiplatelet or antithrombotic drugs within the last 30 days 3. Have a history of peptic ulcer disease 4. Are treated with insulin 5. Have high blood pressure (>150 mmHg systolic or >100 mmHg diastolic 6. Have a known bleeding disorder 7. Have a known gastrointestinal disorder 8. Have evidence of severe hepatic disease or ALT >3 times the upper limit of normal at screening 9. Have evidence of severe renal dysfunction or estimated glomerular filtration rate (eGFR) <40ml/min/1.73m2 at screening 10. Have a contraindication to ASA, such as allergy or active bleeding 11. Have a planned intervention or surgery in the next 3 months 12. Are pregnant or lactating women 13. Are currently taking part, or have completed, an Investigational Medicinal Product (IMP) trial within the last 3 months 14. Are unsuitable for the trial as decided by a clinician |
| Anticipated start date | 30/11/2011 |
| Anticipated end date | 31/05/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | Planned Sample Size: 24; UK Sample Size: 24 |
| Interventions |
Acetylsalicylic acid (ASA), Three two-week treatment regimens will be applied in randomized order in participant individuals, namely:
1. ASA 100mg once daily 2. ASA 200mg once daily 3. ASA 100mg twice daily There will be a two-week washout period between each treatment period.; Follow Up Length: 3 month(s); Study Entry : Registration and One or More Randomisations |
| Primary outcome measure(s) | Change in platelet reactivity between baseline and the end of each treatment period.; Timepoint(s): Measures of platelet reactivity taken at baseline and at the end of each treatment period |
| Secondary outcome measure(s) | A variety of COX-1 dependent and independent platelet function tests.; Timepoint(s): Platelet function tests carried out at baseline and at the end of each treatment period |
| Sources of funding | British Heart Foundation (BHF) (UK) Grant Codes: PG/11/29/28852 |
| Trial website | |
| Publications | |
| Contact name | Prof Rury Holman |
| Address |
Diabetes Trials Unit
Oxford Centre for Diabetes, Endocrinology and Metabolism Old Road, Headington |
| City/town | Oxford |
| Zip/Postcode | OX3 7LJ |
| Country | United Kingdom |
| trg@dtu.ox.ac.uk | |
| Sponsor | University of Oxford (UK) |
| Address |
Research Services
Clinical Trials and Research Governance Joint Research Office Block 60 Churchill Hospital, Headington |
| City/town | Oxford |
| Zip/Postcode | OX2 6HE |
| Country | United Kingdom |
| Sponsor website: | http://www.admin.ox.ac.uk/researchsupport/ctrg/ |
| Date applied | 31/01/2012 |
| Last edited | 14/02/2012 |
| Date ISRCTN assigned | 31/01/2012 |
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