Aspirin resistance in patients with chronic cerebrovascular disease MedDRA version: 9.1 Level: LLT Classification code 10045652 Term: Unspecified cerebrovascular disease
Conditions
Interventions
Trade Name: Cavinton
Pharmaceutical Form: Injection*
Trade Name: Aspirin Protect
Pharmaceutical Form: Tablet
Sponsors
Gedeon Richter Plc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • CT or MRI verified stroke due to large-vessel atherosclerosis according to TOAST criteria, which occurred more than 3 months before enrolment. • Patient receives 100 mg acetyl-salicylicum daily at least 1 month prior the enrollment, and the platelet inhibitor effect of acetyl-salicylicum is less than 40% (measured by optical aggregometry) at the screening. • Age between 30 and 80 years (both males and females). • 18 kg/m2 = BMI = 35 kg/m2 (and the minimal body weight is 40 kg) • Signed Informed Consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Ischaemic stroke or haemorrhagic stroke due to non-large-vessel atherosclerosis according to TOAST criteria. • Other anticoagulant or antiaggregant therapy except for acetyl-salicylicum treatment. • Other severe concomitant disease (chronic inflammation, endocrine-, hematology disease or malignancy). • Uncontrolled hypertension (systolic > 180 Hgmm, diastolic > 110 Hgmm). • If QTc > 500 msec. • Any clinically significant abnormality in clinical laboratory tests. Screening haematology and biochemistry laboratory tests must be within defined limits including full blood count within the normal range (or not clinically significantly abnormal), liver enzymes not exceed three times the upper limit of normal range, alkaline phosphatase, bilirubin not exceed twice the upper limit of normal range. • Having received the investigational product (vinpocetine) during 1 month prior to the study without 1 month long wash-out period. • Alcohol or drug abuse in the medical history within the past 2 years, or current chronic or intermittent users of illicit drugs. • Known hypersensitivity to acetyl-salicylicum or vinpocetine or any of the excipients of the products. • Aspirin or other NSAID precipitate attacks of asthma, bronchospasm, acute rhinitis or urticaria. • Active or suspected peptic or duodenal ulcer or history of recurrent peptic or duodenal ulcer or gastrointestinal bleeding or other active bleeding or bleeding disorders. • Severe physical or mental (for example: severe dementia) concomitant disorder that might confound the conduct or result of the trial. • Any kind of acute or chronic disorder, which can influence the level of the inflammatory markers. • Lactating or pregnant women or women of child-bearing potential without appropriate contraceptive treatment. • Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study or to cooperate on the necessary level. • Evidence of an uncooperative attitude. • Patients who have participated in a study of an investigational drug or device within 3 months of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the add-on effect of vinpocetine infusion to haemorheological effect of 100 mg acetyl-salicylicum in post-stroke patients.;Secondary Objective: To investigate the safety and tolerability of co-administration of vinpocetine infusion and Aspirin Protect tablet.;Primary end point(s): Exploratoric study | — |
Countries
Hungary
Outcome results
None listed