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Clinical Trial to Evaluate the Safety of Continuous IV Tirofiban in Acute Ischemic Stroke

NCT04818944 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2022-09-21

No results posted yet for this study

Summary

We will recruit men and non-pregnant women of any ethnic background between the age ≥ 18 and ≤ 90 years that have acute ischemic stroke and underwent Mechanical Thrombectomy (MT) with TICI 2b or 2b following MT. These subject's will be will be randomized to placebo vs. Tirofiban after consent is obtained. This will be administered via continuous IV starting within 60 minutes of MT procedure completion. At the end of the 24 hour continuous IV dosing period a CT angiography and CT perfusion (CTA/CTP) will be obtained. The rest of the subjects inpatient hospital stay will be done per standard of care. The subject's NIHSS and modified Rankin Score (mRS) will be assessed at 90 days.

Conditions

Interventions

DRUG

Tirofiban Hydrochloride

Tirofiban Hydrochloride will be dosed for 24 hours post MT via continuous IV

DRUG

Placebo

Saline will be dosed for 24 hours post MT via continuous IV

Sponsors & Collaborators

  • University of Iowa

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2025-01-01
Completion
2025-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04818944 on ClinicalTrials.gov