The objective of this trial is to investigate whether adding acute APT to rt-PA thrombolysis in ischemic stroke reduces death or dependency at 3 months.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is poor functional health at 3 months defined as
dependency or death (mRS 3 * 6).
Secondary outcome
Secondary outcomes are symptomatic intracranial or serious systemic
haemorrhages within 48 hours, neurological symptoms at 7 * 10 days and
survival, disability assessed with the ALDS scale, functional health on the
full ordinal range of the modified Rankin Scale at 3 months and the causes of
poor outcome.
Background summary
Stroke is a major cause of acquired disability in the Netherlands. In recent
years the acute treatment of ischemic stroke improved significantly. Treatment
with rt-PA within 3 hours reduced the relative risk of poor outcome by 20%,
leading to a favourable outcome of 40%. Treatment with rt-PA however only
addresses the degradation of fibrin while a thrombus is formed by both fibrin
formation and platelet activation. Currently no treatment is given in the acute
phase of ischemic stroke to inhibit the platelet activation, while in acute
myocardial infarction outcome improved by adding acute antiplatelet therapy to
thrombolysis.
Subgroup-analysis of patients in the NINDS trial already on anti-platelet
therapy (APT) revealed that they had a better outcome compared to thrombolysed
patients without APT. Patients already on APT had less clinical deteriorations
(often caused by re-occlusion), without increase in the risk of intracranial
haemorrhages. We therefore hypothesize that the addition of APT to rt-PA
improves the efficiency and speed of thrombolysis itself and prevents
re-occlusion.
Study objective
The objective of this trial is to investigate whether adding acute APT to rt-PA
thrombolysis in ischemic stroke reduces death or dependency at 3 months.
Study design
Multi-center clinical trial with web-based Oracle Clinical data entry using a
PROBE design: Prospective, Randomized, Open label design with Blind Endpoint
assessment.
Intervention
Patients are randomized to receive either 300 mg acetylsalicyclicacid iv
(Aspégic) within 1,5 hours after the rt-PA bolus or standard care of rt-PA
without Aspégic.
Study burden and risks
Patients risk hemorrhages. Trials have shown that patients using classic
antiplatelet therapy, like the ASA used in the this trial, prior to the stroke
did not suffer more hemorrhage and bleeding. The risk of these complications
are therefore estimated to be limited while the benefits are estimated to be
high in term of less death and dependency after three months.
Postbus 22660
1100 DD Amsterdam
NL
Postbus 22660
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
* patients with an acute ischemic stroke receiving rt-PA thrombolysis
* age * 18 years
* written informed consent is obtained
Exclusion criteria
* known APT in the previous 5 days(in case of uncertainty the patient may be included)
* known thrombocytopenia (thrombocyte count * 100 * 10E9/l)
* known contra-indications to ASA treatment (e.g. previous adverse reaction to ASA)
* Known anticoagulans usage in the previous 5 days
* known legal incompetence of the patient prior to this stroke
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-006829-13-NL |
| Other | Nederlandse trialreg. 822 |
| CCMO | NL15747.018.08 |