Ischemic Stroke Clinical Trial
Official title:
Dipyrone Nullifies Aspirin Antiplatelet Effects in Stroke-Patients
| Verified date | March 2015 |
| Source | Heinrich-Heine University, Duesseldorf |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Observational |
Many patients suffer from acute and chronic pain. The incidence of chronic pain correlates
with increased age. Most of patients rely on analgesic medication to control the pain.
Dipyrone is an extensively used drug in Western and Eastern Europe as well as Central and
South America, largely due to its favorable analgesic and antipyretic effects in conjunction
with a low incidence of gastrointestinal complications when compared to other non-steroidal
anti-inflammatory drugs (NSAIDs).
Aspirin is the backbone of antiplatelet therapy in patients after ischemic stroke. However,
it is known that there are substantial inter-individual response variabilities to
antiplatelet medication. Furthermore, patients with impaired response to aspirin have a
significant higher risk of recurrent cerebrovascular events. The investigators have recently
shown that co-medication with aspirin and dipyrone in patients with coronary artery disease
lead to insufficient antiplatelet effects of aspirin.
The incidence of chronic pain is very high in patients with ischemic stroke. Therefore, in
this study the investigators aim to examine, if co-medication of aspirin and dipyrone
interaction also occurs in patients after ischemic stroke.
| Status | Completed |
| Enrollment | 61 |
| Est. completion date | February 2015 |
| Est. primary completion date | February 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Age = 18 years - Patients with ischemic stroke and ASS-medication (80-320 mg/day) with/without analgesic comedication Exclusion Criteria: - Reanimation - cardiogenic shock |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Division of Cardiology, Pulmonary Disease and Vascular Medicine | Düsseldorf |
| Lead Sponsor | Collaborator |
|---|---|
| Heinrich-Heine University, Duesseldorf |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Laboratory response to aspirin therapy in metamizole co-medicated Stroke patients | Baseline | No | |
| Secondary | Major adverse cardiac and cerebrovascular events (MACCE Events) during hospital stay | participants are followed until discharge up to 4 weeks | No |
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