AzTrials
AzTrials

Acute Ischemic StrokePhase 1/2iTREMTNCT04818944

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

A Phase 1/2 study testing Tirofiban Hydrochloride in people with Acute Ischemic Stroke and Ischemic Stroke, run by University of Iowa at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Acute Ischemic Stroke, Ischemic Stroke
What is being tested?
Tirofiban Hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Mar 2023to 1 Sep 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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
Show all 45Show fewer
  • 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 %
  • Elevated PTT above laboratory upper limit of normal
  • Creatinine > 4 mg/dl
  • Ongoing renal dialysis, regardless of creatinine
  • Received Low Molecular Weight heparins (such as Dalteparin, Enoxaparin, Tinzaparin) in full dose within the previous 24 hours
  • Abnormal PTT within 48 hours prior to randomization after receiving heparin or a direct thrombin inhibitor (such as bivalirudin, argatroban, dabigatran or lepirudin)
  • Received Factor Xa inhibitors (such as Fondaparinux, apixaban or rivaroxaban) within the past 48 hours
  • Received iv tPA
  • Pre-existing neurological or psychiatric disease which confounded the neurological or functional evaluations e.g., baseline modified Rankin score >3
  • Other serious, advanced, or terminal illness or any other condition that the investigator felt would pose a significant hazard to the patient if tirofiban therapy was initiated a. Example: known cirrhosis or clinically significant hepatic disease
  • Current participation in another research drug treatment or interventional device trial
  • Informed consent from the patient or the legally authorized representative was not or could not be obtained
  • High density lesion consistent with hemorrhage of any degree
  • ASPECT score < 6
  • Deployment of a stent INTRA and/or EXTRA-cranial
  • Did not receive MT
  • TICI score of 3 post MT
  • Extravasation of contrast during procedure
  • Perforation of any vessel during procedure.
  • Renal dysfunction
  • History of gastrointestinal hemorrhage or major systemic hemorrhage within 30 days, hemoglobin less than 8 g/dL on admission, INR ≥1.5, severe liver impairment as defined as AST, ALT, AP, GGT > 2 x normal
  • Creatinine clearance <30 mL/min.
  • Major surgery within 30 days with contra-indication to antiplatelet therapy
  • Currently pregnant.
  • Contraindication for MRI
  • Contra-indication to antiplatelet tirofiban:
  • Active internal bleeding or a history of bleeding diathesis within the previous 30 days
  • History of thrombocytopenia following prior exposure to AGGRASTAT
  • History, symptoms, or findings suggestive of aortic dissection
  • Acute pericarditis
  • Actual Body Weight >150kg (due to the lack of safety data)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: A Pilot, Exploratory Clinical Trial to Evaluate the Safety of Using Continuous IV Infusion of Tirofiban (24 Hours) Including Its Efficacy in Improving Perfusion Post Mechanical Thrombectomy in Acute Ischemic Stroke

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.

Read the detailed description

Procedures:

  1. Potential subject present with acute ischemic changes to our Emergency department (ED) and evaluated by stroke neurologist.
  2. If the potential subject is a candidate for MT then the patient will be screened for inclusions / exclusions criteria.
  3. Patient will undergo MT per standard of care (SOC).
  4. At the end of the procedure, the interventionist will assign a specific score for reperfusion following MT.
  5. If the interventionist assign a score of TICI 2b, then the potential subject will be eligible to be randomized if she/he meets all the other inclusion /exclusion criteria.
  6. If the potential subject has score of TICI 2b after MT and meets all the other inclusion/exclusion criteria, then the power of attorney( POA) /LAR of the potential subject will be approached and informed about the study.
  7. If the POA /LAR signs the informed consent, then the subject will be randomized to placebo vs. Tirofiban.
  8. The randomization will be 1:1 and will be done by the Investigational Drug Service (IDS) pharmacy.
  9. The informed consent must be signed within 60 min from the end of the MT.
  10. If the informed consent is obtained, then the agent (placebo or Tirofiban) will must initiated no later than 60 min from the end of the MT.
  11. The subject will be transferred to SNICU per SOC.
  12. The infusion will continue for 24 hours then stopped.
  13. At the end of the 24 hours of infusion a CTA/CTP will be obtained to assess perfusion.
  14. If the subject neurological exam deteriorates / worsen during the infusion, the medication will be stopped and unblinded. Non contrast HCT will be obtained immediately to assess if there is a new hemorrhage.
  15. If there is hemorrhage and the subject was on Tirofiban then a pack of platelet will be ordered infused immediately. If the subject is on placebo, then no need to infuse a pack of platelets.
  16. Platelet count will be assess daily for 48 hours from initiating the medication
  17. If the platelet count drops below 20,000, then the medication will be stopped immediately and unblinded.
  18. Th rest of the hospitalization will be done per SOC.
  19. The subject's NIHSS and mRS will be assessed at 90 days.
Being tested
Tirofiban Hydrochloride, Placebo
Keywords
Mechanical Thrombectomy, Tirofiban, Distal Vessel Reperfusion
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tirofiban HydrochlorideDrug

    Also called Aggrastat

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

  • PlaceboDrug

    Also called Saline

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

Study groups in NCT04818944
Study groupRoleWhat they receive
Treatment Arm (tirofiban hydrochloride (AGGRASTAT®))ExperimentalSubjects 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.
Receives: Drug: Tirofiban Hydrochloride
Placebo ArmPlacebo comparatorSubjects 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intracranial Hemorrhage

    Incidence of intracranial hemorrhage

    Measured: Up to 2 weeks post enrollment

  2. Infract Size

    Infract size as calculated through imaging methods

    Measured: Up to 2 weeks post enrollment

Secondary outcomes (2)

  1. Modified Rankin Score

    mRS at clinically indicated follow-up visit. Relative frequency of "good outcome" as defined by dichotomized mRS score 0-2

    Measured: 90 Day post- discharge follow up

  2. NIH Stroke Scale

    NIHSS at clinically indicated follow-up visit.

    Measured: 90 Day post- discharge follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2021
  2. Study start1 Mar 2023 (estimated)
  3. Primary completion1 Jan 2025 (estimated)
  4. Study completion1 Sep 2025 (estimated)

Why it stopped: PI has left the Institution

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04818944
Sponsor's protocol ID
202010341
Acronym
iTREMT
Status last verified
Sep 2022
First submitted
23 Mar 2021
Last updated
21 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Tirofiban Hydrochloride in people with Acute Ischemic Stroke and Ischemic Stroke, run by University of Iowa at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intracranial Hemorrhage (time frame: Up to 2 weeks post enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04818944.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
iTREMT Clinical Trial NCT04818944 | AzTrials