Anticoagulant medication for the treatment of patients with teared brain supplying vessels

Phase 1

Conditions: cervical artery dissection
MedDRA version: 20.0Level: LLTClassification code 10068353Term: Intimal dissectionSystem Organ Class: 100000004866
MedDRA version: 20.1Level: LLTClassification code 10055221Term: Ischemic strokeSystem Organ Class: 100000004852
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2015-003200-23-DK

Lead Sponsor: niversity Hospital Basel; Neurology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 169

Inclusion Criteria

1.Acute ischemic or non-ischemic symptoms within 2 weeks
2.Verification of CAD-diagnosis (carotid and/or vertebral) by MR-techniques (at least one):
•mural hematoma or
•pseudo-aneurysm or
•long filiform stenosis or
•intimal flap or
•double lumen or
•occlusion situated more than 2 cm above the bifurcation of the carotid artery, revealing a pseudo aneurysm or a long filiform stenosis after recanalisation.
3.Written informed consent by patient or next-to-kin
4.24h latency period in case of thrombolysis
5.Age > 18 years by time of inclusion (no upper age limit)

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 169
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. MR-contraindications (claustrophobia precluding MRI: patients agreeing to undergo MRI scanning with mild sedation may be entered into the study)
2. Contraindications to the use of ASA or vitamin K-antagonists (see below)
3. Pregnancy
4. If the patient
• is allergic to Warfarin or to any of the other ingredients of this medicine
• is pregnant or may become pregnant or has had a baby in the last 48 hours
• has or has ever had any bleeding problems
• has recently had a stroke caused by bleeding in the brain
• has had surgery within the last 72 hours or is going to have surgery in the next 72 hours
• is taking non-steroidal inflammatory drugs (NSAIDs), aspirin or anti-clotting medicines (https://www.drugs.com/uk/marevan-3mg-tablets-leaflet.html)
• has a recent history of stomach or intestinal bleeding;
• has a bleeding disorder such as hemophilia; or
• has ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID (non-steroidal anti-inflammatory drug) such as Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others. (https://www.drugs.com/aspirin.html)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the non-inferiority of acetylsalicylic acid (ASA) to anti- coagulant treatment (vitamin K antagonists) in patients with cervical artery dissection (CAD) with regard to outcome and complication measures;Secondary Objective: not appicable;Primary end point(s): Primary composite outcome measure – labeled Cerebrovascular Ischemia, major Hemorrhagic events or Death (CIHD) – includes the following efficacy and safety outcome measures during the treatment period: (i) occurrence of any Stroke (including retinal infarction), new acute lesions on diffusion- weighted MRI (ii) any major extracranial hemorrhage, any symptomatic intracranial hemorrhage and any asymptomatic micro- or macrobleeds, (iii) death.;Timepoint(s) of evaluation of this end point: 14 +/- 10 days after baseline<br>90 +/- 30 days after baseline<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. New ischemic stroke (including retinal infarction)<br>2. new acute lesions on diffusion-weighted MRI<br>3. any major extracranial hemorrhage<br>4. any symptomatic intracranial hemorrhage<br>5. any asymptomatic micro- or macrobleeds<br>6. any death<br>7. any increase in volume of the vessel wall hematoma at the follow- up cervical MRI as compared to the baseline MR-scan.<br>8. independence in activity of daily living (modified Rankin scale 0-2)<br>at 3 months and at 6 months<br>9. excellent functional outcome (modified Rankin scale 0,1) at 3 month and at 6 months<br>10. any TIA (classical Definition)<br>11. recurrent cervical artery dissection<br><br>;Timepoint(s) of evaluation of this end point: 14 +/- 10 days after baseline<br>90 +/- 30 days after baseline<br>

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