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

NCT04818944 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 202010341
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Acute Ischemic Stroke; Ischemic Stroke

Keywords

Mechanical Thrombectomy; Tirofiban; Distal Vessel Reperfusion

Outcome Measures

Primary Outcomes (2)

• Intracranial Hemorrhage

  Incidence of intracranial hemorrhage

  Up to 2 weeks post enrollment

• Infract Size

  Infract size as calculated through imaging methods

  Up to 2 weeks post enrollment

Secondary Outcomes (2)

• Modified Rankin Score

  90 Day post- discharge follow up

• NIH Stroke Scale

  90 Day post- discharge follow up

Study Arms (2)

Treatment Arm (tirofiban hydrochloride (AGGRASTAT®))

EXPERIMENTAL

Subjects will receive an active dose via continuous IV at a rate of 0.10µg/kg/min (actual weight). This rate will begin within one hour of mechanical thrombectomy completion and will be terminated 24 hours after the initial administration time.

Drug: Tirofiban Hydrochloride

Placebo Arm

PLACEBO COMPARATOR

Subjects will receive placebo (saline) via continuous IV. This will begin within one hour of mechanical thrombectomy completion and will be terminated 24 hours after the initial administration time.

Drug: Placebo

Interventions

Tirofiban Hydrochloride DRUG

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

Also known as: Aggrastat

Treatment Arm (tirofiban hydrochloride (AGGRASTAT®))

Placebo DRUG

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

Also known as: Saline

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 90 years
• Acute ischemic stroke (AIS)
• Onset of AIS 6-24 hrs.
• NIHSS score ≥ 6
• AIS due to LVO
• core infarct \<30cc or ASPECT score \> 6.
• Received MT per SOC
• TICI score of 2B, or TC post MT.
• Able to be imaged by MRI
• Patient or their Legally Authorized Representative (LAR) has provided written informed consent.

You may not qualify if:

• Known allergy or hypersensitivity to tirofiban
• Previous stroke in the past 90 days
• Previous intracranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arterial venous malformation
• Clinical presentation suggested a subarachnoid hemorrhage, even if initial CT scan was normal
• Surgery or biopsy of parenchymal organ in the past 30 days
• Trauma with internal injuries or ulcerative wounds in the past 30 days
• Severe head trauma in the past 90 days
• Systolic blood pressure persistently \>180mmHg post-MT despite antihypertensive intervention.
• Diastolic blood pressure persistently \>105mmHg post-MT despite antihypertensive intervention.
• Serious systemic hemorrhage in the past 30 days.
• Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \>1.5
• Positive urine pregnancy test for women of childbearing potential
• Glucose \<50 or \>400 mg/dl
• Platelets \<100,000/mm3
• Hematocrit \<25 %

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tirofiban; Sodium Chloride

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: All study staff is masked to randomization except the following: nursing staff administrating drug, pharmacy staff, statistician, and independent safety assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 26, 2021
• Study Start: March 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: September 1, 2025
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

US (1)