Assessment of blood concentration of an enzyme named Active Thrombin-Activatable Fibrinolysis Inhibitor (TAFIa) in Patients at acute stage of Stroke

Phase 1

• Conditions: Acute Ischemic Stroke; MedDRA version: 20.0Level: LLTClassification code 10055221Term: Ischemic strokeSystem Organ Class: 100000013700; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-002760-41-ES
• Lead Sponsor: institute de Recherches Internacionales Servier (promotor internacional)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-10
• Study Completion: 2018-04-05
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

- Adult patients (= 18 years old) within 4.5 hours after ischemic stroke symptoms onset (or last time known normal),
- Imaging evidence of cerebral artery occlusion in anterior circulation: proximal (internal carotid artery (ICA), middle cerebral artery M1 (MCA-M1) or distal (MCA-M2, MCA-M3) arteries,
- Eligible for pharmacological thrombolysis alone or followed by EVT according to current clinical guidelines,
- Complete informed consent signed (by the patient or an authorized representative according to local regulation) prior to participation in the trial or within 12 hours if an abbreviated informed consent has been signed prior to the participation in the trial (by the patient or an authorized representative according to local regulation) or orally agreed by the patient and witnessed by a person according to local regulation.
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 7
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33

Exclusion Criteria

- Any known serious disease (including active malignancy, active infection) likely to interfere with the conduct of the study, according to investigator’s judgment,
- Known pregnant or breastfeeding woman,
- Patients unlikely to cooperate in the study,
- Participation in another interventional study at the same time or within the past 3 months (participation in non-interventional registries or epidemiological studies is allowed).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified