E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Aspirin resistance in patients with chronic cerebrovascular disease |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045652 |
E.1.2 | Term | Unspecified cerebrovascular disease |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the add-on effect of vinpocetine infusion to haemorheological effect of 100 mg acetyl-salicylicum in post-stroke patients. |
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E.2.2 | Secondary objectives of the trial |
To investigate the safety and tolerability of co-administration of vinpocetine infusion and Aspirin Protect tablet. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |