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

NACompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

August 1, 2021

Primary Completion Date

April 30, 2024

Study Completion Date

August 30, 2024

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."

Trial Locations (4)

20900

Ospedale San Gerardo, Monza

27100

IRCCS Fondazione Istituto Neurologico Mondino, Pavia

67051

Ospedale Civile SS. Filippo e Nicola di Avezzano, Avezzano

00189

Ospedale Sant'Andrea, Rome

All Listed Sponsors
collaborator

San Gerardo Hospital

OTHER

collaborator

Università degli Studi dell'Aquila

OTHER

collaborator

University of Roma La Sapienza

OTHER

collaborator

IRCCS Fondazione Istituto Neurologico Mondino Pavia

UNKNOWN

collaborator

Istituto Di Ricerche Farmacologiche Mario Negri

OTHER

lead

University of Milano Bicocca

OTHER

NCT04400981 - Clinical Trial on Remote Ischemic Conditioning in Acute Ischemic Stroke Within 9 Hours of Onset in Patients Ineligible to Recanalization Therapies | Biotech Hunter | Biotech Hunter