Clinical Trial on Remote Ischemic Conditioning in Acute Ischemic Stroke Within 9 Hours of Onset in Patients Ineligible to Recanalization Therapies

Summary

Phase II, prospective, randomized, multicenter, open-label, pilot clinical trial comparing remote ischemic conditioning (RIC) plus standard medical therapy to standard medical therapy alone, in patients with acute ischemic stroke within 9 hours of stroke onset that are not eligible to recanalization therapies.

Conditions

• Ischemic Stroke

Interventions

PROCEDURE

Remote ischemic conditioning

Remote ischemic conditioning will be applied immediately after randomization in the Emergency Department, through a standard blood pressure cuff placed around the non-paretic arm. The protocol includes 4 cycles of intermittent manually induced upper limb ischemia, alternating 5 minutes of inflation (20mmHg above systolic blood pressure) and 5 minutes of deflation.

OTHER

standard medical therapy

Standard medical therapy comprises single antiplatelet therapy, either aspirin given in a total dose ranging between 100 to 300 mg per day on days 1-5 and followed by aspirin 100mg/day on days 1-5 followed by aspirin 100mg/day, or Clopidogrel 75mg/day (at the discretion of the patient's attending physician), unless an indication for early anticoagulation (e.g. atrial fibrillation, mechanical heart valve, deep venous thrombosis, pulmonary embolism, antiphospholipid antibody syndrome, hypercoagulable state) or dual antiplatelet therapy (e.g. early carotid stenting) is present. All patients will receive standard deep venous thrombosis (DVT) prevention therapy together with appropriate treatment for blood pressure control, glycemic control and cholesterol reduction.

Sponsors & Collaborators

• San Gerardo Hospital

  collaborator OTHER

• Università degli Studi dell'Aquila

  collaborator OTHER

• University of Roma La Sapienza

  collaborator OTHER

• IRCCS Fondazione Istituto Neurologico Mondino Pavia

  collaborator UNKNOWN

• Istituto Di Ricerche Farmacologiche Mario Negri

  collaborator OTHER

• University of Milano Bicocca

  lead OTHER

Principal Investigators

• Simone Beretta, MD, PhD · San Gerardo Hospital

• Susanna Diamanti, MD, PhD · San Gerardo Hospital

• Carlo Ferrarese, MD, PhD · San Gerardo Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-01

Primary Completion

2024-04-30

Completion

2024-08-30

Countries

• Italy

Study Locations