AMBDAP
Dual antiplatelet therapy in the acute phase following stroke and transient ischaemic attack (TIA): which is the best regimen?
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Status:
Completed. Recruitment completed in May, 2009. Currently we are analyzing the data and preparing the paper (October, 2009).
Purpose:
To determine optiminal therapy to prevent recurrent stroke
Location(s):
United Kingdom
Year Started:
2005
Year Finished:
2009
Design:
Interventional, randomised double-blinded single-centre study.
Inclusion Criteria
1. Women or men aged greater than 18 years
2. Patients with greater than or equal to 50% carotid artery stenosis
3. Symptoms of TIA or stroke within the last month
4. Baseline magnetic resonance imaging (MRI) or computed tomography (CT) imaging has been performed
5. Consented to take part in the study
Exclusion Criteria
1. Currently taking antiplatelet/antithrombotic medication other than aspirin (although low does prophylactic subcutaneous heparin for deep vein thrombosis [DVT] prophylaxis will be allowed)
2. Patients with prosthetic heart valves who have gaseous embolic signals
3. Where clopidogrel or dipyridamole is contra-indicated
4. Carotid endarterectomy planned within the next month
5. Pregnant and lactating women
Patient Involvement:
Patients randomised to aspirin and dipyridamole will continue with this treatment long-term as this is the standard treatment regimen. Patients randomised to aspirin and clopidogrel will continue will this treatment for one month, and then will revert to the aspirin and dipyridamole combination long-term. Patients will be followed up for recurrent strokes and TIA up until one month, or until carotid endarterectomy or stenting is performed.
This is a pragmatic study to compare two anti-platelet regimes used in clinical practice. The loading dose of clopidogrel of 300 mg followed by 75 mg a day has been shown to have a rapid efficacy with maximal effect on the rate of embolisation within 24 hours. Dipyridamole SR has been shown to demonstrate maximal platelet concentrations within two hours and a loading dose is therefore unnecessary.
Primary Outcome:
The number of embolic signals (using international consensus criteria) detected during transcranial doppler recording from ipsilateral middle cerebral artery at 48 hours after study entry.
Secondary Outcome:
No secondary outcome measures.
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Source of Information:
Controlled-trials.com
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Web Links and Publications:
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This information last updated on: 10/27/2009
Reviewed on: 10/19/2009.
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