AzTrials
AzTrials

Ischemic StrokePhase 2OPTIMISTICNCT04851457

One Pass Tirofiban In Management of Ischemic Stroke Thrombectomy In China

A Phase 2 study testing Intravenous tirofiban combination therapy in people with Ischemic Stroke, run by Shanghai East Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

In recent years, the positive results of trials for mechanical thrombectomy (MT) have brought a new era for large artery occlusion patients, especially those beyond the time window of intravenous thrombolysis. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Ischemic Stroke
What is being tested?
Intravenous tirofiban combination therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
6 Apr 2021to 15 Oct 2023
Phase
Phase 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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-85 years (including 18 and 85);
  • Acute ischemic stroke within 24 hours of onset, and NIHSS >5 points;
  • Acute large vessel occlusion, including internal carotid artery, M1 segment of middle cerebral artery, M2 segment of middle cerebral artery;
  • Multimodal CT/MRI imaging was completed before thrombectomy, and the following criteria were met: penumbra>10ml, infarct core volume <70ml, and mismatch rate >1.2;
  • Planned to receive endovascular treatment;
  • Informed consent was obtained.

Who cannot join

  • History of atrial fibrillation or atrial flutter, or 12-lead ECG before randomization and after admission showing atrial flutter or atrial fibrillation;
  • Treated with intravenous thrombolysis for this stroke or currently taking new oral anticoagulant drugs, warfarin, ticagrelor and other drugs that may increase the risk of bleeding;
  • Pre-stroke disability (pre-stroke mRS score > 2);
  • Severe comorbidity (such as severe cardiopulmonary dysfunction, or the terminal stage of malignant tumors with expected survival less than 90 days);
  • CT shows hypodensity lesions in more than 1/3 of the territory of the middle cerebral artery;
  • Allergy to tirofiban or having any contraindications to the use of tirofiban (patients with active internal bleeding, history of intracranial hemorrhage, intracranial tumors, arteriovenous malformations, and intracranial aneurysms, or patients resulting in thrombocytopenia from the use of tirofiban previously);
Show all 10Show fewer
  • Contraindications to the contrast agents used in multimodal CT/MRI examination (such as allergy to the contrast agents, etc.);
  • Pregnant or breastfeeding women;
  • Patients currently participating in other clinical study trials;
  • Other conditions determined by the investigator are not suitable for inclusion in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Gang Li

    Shanghai, Shanghai Municipality, 200123

Other trials in China

About this study

Official title: Safety and Efficacy of Tirofiban in Acute Ischemic Stroke Patients Treated With Mechanical Thrombectomy-A Prospective, Randomized, Controlled, Open-Label, Assessor-Blind, Multicenter Clinical Study

In recent years, the positive results of trials for mechanical thrombectomy (MT) have brought a new era for large artery occlusion patients, especially those beyond the time window of intravenous thrombolysis. However, interventional procedures can cause endothelial injuries leading to local activation of platelet aggregation and subsequent thromboembolic complications or early re-occlusion.Tirofiban is a specific antagonist of the platelet glycoprotein (GP) IIb/IIIa receptor, which is considered highly effective against the final common pathway of platelet aggregation and preventing vascular reocclusion. However, there is no consensus on if AIS patients treated with MT also benefit from intravenous tirofiban. This study aims to evaluate the effectiveness and safety of profiles of tirofiban during MT and provide reliable clinical evidence for the treatment of tirofiban in AIS patients.

Read the detailed description

This study is a multicenter, prospective, open-label, randomized controlled, blinded-endpoint trial with two parallel groups and a 3-month follow-up. A total of 200 eligible participants recruited from 4-6 stroke centers will be randomly allocated to either an experimental group (intravenous tirofiban + MT therapy) or a control group (MT alone) in a 1:1 ratio. The primary outcome is a composite endpoint, including the rate of recanalisation after the first embolectomy and the risk of symptomatic intracerebral haemorrhage. The secondary outcomes include clinical and neuroimaging outcomes, procedure-related complications, and adverse events to evaluate the effects of MT in combination with tirofiban treatment compared to MT alone in AIS patients. Intention-to-treat (ITT) analysis will be undertaken in this study, and the full analysis set (FAS) population serves as the primary population for the analysis of efficacy data.

Conditions
Ischemic Stroke
Being tested
Intravenous tirofiban combination therapy
Keywords
Acute Ischemic Stroke, Tirofiban, Mechanical thrombectomy, Revascularisation, Haemorrhage
Medical subject headings
Ischemic Stroke, Hemorrhage

What participants receive

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

  • Intravenous tirofiban combination therapyDrug

    Also called Tirofiban

    Patients will enter the tirofiban treatment protocol immediately within half an hour after randomization and prior to the femoral artery puncture. Tirofiban is administered as an intravenous bolus dose of 10 μg/kg injection within 3 min and then by an intravenous infusion at a rate of 0.1 μg/(kg·min) for 24 hours.

Study groups in NCT04851457
Study groupRoleWhat they receive
Intervention groupExperimentalThe participants in the experimental group will receive intravenous tirofiban combined with a standard MT protocol recommended by the current guidelines for the management of AIS
Receives: Drug: Intravenous tirofiban combination therapy
Control groupNo interventionPatients are treated with MT therapy with no antiplatelet drugs (intravenous or intra-arterial) are administered. Besides, they will receive a standard pharmacological treatment as per current clinical guidelines.

What is being measured

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

  1. Composite rates of target vessel revascularization and no symptomatic intracerebral haemorrhage

    Target vessel revascularization is defined as a modified thrombolysis in cerebral infarction (mTICI) grade after onepass thrombectomy procedure over grade 2b. Symptomatic intracerebral haemorrhage is defined according to per Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) criteria.

    Measured: 24-72hours after thrombectomy;

Secondary outcomes (5)

  1. Recanalisation rates of the target vessel

    Neuroimaging outcomes

    Measured: 24-72 hours after thrombectomy;

  2. Dichotomized mRS score/ ordinal mRS score

    Functional prognosis of the patient，clinical outcomes

    Measured: The 90-day after randomisation

  3. Symptomatic intracerebral haemorrhage

    procedure-related complications and adverse events

    Measured: By the end of the 90-day follow-up

  4. Death

    procedure-related complications and adverse events

    Measured: By the end of the 90-day follow-up

  5. The number of thrombectomy times

    Treatment information

    Measured: By the end of the 90-day 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 posted20 Apr 2021
  2. Study start6 Apr 2021
  3. Primary completion8 Jul 2023
  4. Study completion15 Oct 2023

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A prospective, randomized, controlled, open-Label, assessor-blind, multicenter clinical study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04851457
Sponsor's protocol ID
2021-OPTIMISTIC
Acronym
OPTIMISTIC
Status last verified
Jan 2024
First submitted
11 Apr 2021
Last updated
9 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Goyal M, Demchuk AM, Menon BK, Eesa M, Rempel JL, Thornton J, Roy D, Jovin TG, Willinsky RA, Sapkota BL, Dowlatshahi D, Frei DF, Kamal NR, Montanera WJ, Poppe AY, Ryckborst KJ, Silver FL, Shuaib A, Tampieri D, Williams D, Bang OY, Baxter BW, Burns PA, Choe H, Heo JH, Holmstedt CA, Jankowitz B, Kelly M, Linares G, Mandzia JL, Shankar J, Sohn SI, Swartz RH, Barber PA, Coutts SB, Smith EE, Morrish WF, Weill A, Subramaniam S, Mitha AP, Wong JH, Lowerison MW, Sajobi TT, Hill MD; ESCAPE Trial Investigators. Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med. 2015 Mar 12;372(11):1019-30. doi: 10.1056/NEJMoa1414905. Epub 2015 Feb 11.

    PubMed 25671798

  • Jovin TG, Chamorro A, Cobo E, de Miquel MA, Molina CA, Rovira A, San Roman L, Serena J, Abilleira S, Ribo M, Millan M, Urra X, Cardona P, Lopez-Cancio E, Tomasello A, Castano C, Blasco J, Aja L, Dorado L, Quesada H, Rubiera M, Hernandez-Perez M, Goyal M, Demchuk AM, von Kummer R, Gallofre M, Davalos A; REVASCAT Trial Investigators. Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med. 2015 Jun 11;372(24):2296-306. doi: 10.1056/NEJMoa1503780. Epub 2015 Apr 17.

    PubMed 25882510

  • Nogueira RG, Jadhav AP, Haussen DC, Bonafe A, Budzik RF, Bhuva P, Yavagal DR, Ribo M, Cognard C, Hanel RA, Sila CA, Hassan AE, Millan M, Levy EI, Mitchell P, Chen M, English JD, Shah QA, Silver FL, Pereira VM, Mehta BP, Baxter BW, Abraham MG, Cardona P, Veznedaroglu E, Hellinger FR, Feng L, Kirmani JF, Lopes DK, Jankowitz BT, Frankel MR, Costalat V, Vora NA, Yoo AJ, Malik AM, Furlan AJ, Rubiera M, Aghaebrahim A, Olivot JM, Tekle WG, Shields R, Graves T, Lewis RJ, Smith WS, Liebeskind DS, Saver JL, Jovin TG; DAWN Trial Investigators. Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct. N Engl J Med. 2018 Jan 4;378(1):11-21. doi: 10.1056/NEJMoa1706442. Epub 2017 Nov 11.

    PubMed 29129157

  • Albers GW, Marks MP, Kemp S, Christensen S, Tsai JP, Ortega-Gutierrez S, McTaggart RA, Torbey MT, Kim-Tenser M, Leslie-Mazwi T, Sarraj A, Kasner SE, Ansari SA, Yeatts SD, Hamilton S, Mlynash M, Heit JJ, Zaharchuk G, Kim S, Carrozzella J, Palesch YY, Demchuk AM, Bammer R, Lavori PW, Broderick JP, Lansberg MG; DEFUSE 3 Investigators. Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion Imaging. N Engl J Med. 2018 Feb 22;378(8):708-718. doi: 10.1056/NEJMoa1713973. Epub 2018 Jan 24.

    PubMed 29364767

  • Kellert L, Hametner C, Rohde S, Bendszus M, Hacke W, Ringleb P, Stampfl S. Endovascular stroke therapy: tirofiban is associated with risk of fatal intracerebral hemorrhage and poor outcome. Stroke. 2013 May;44(5):1453-5. doi: 10.1161/STROKEAHA.111.000502. Epub 2013 Mar 5.

    PubMed 23463755

  • Teng D, Pannell JS, Rennert RC, Li J, Li YS, Wong VW, Chien S, Khalessi AA. Endothelial trauma from mechanical thrombectomy in acute stroke: in vitro live-cell platform with animal validation. Stroke. 2015 Apr;46(4):1099-106. doi: 10.1161/STROKEAHA.114.007494. Epub 2015 Feb 24.

    PubMed 25712942

  • Muniz-Lozano A, Rollini F, Franchi F, Angiolillo DJ. Update on platelet glycoprotein IIb/IIIa inhibitors: recommendations for clinical practice. Ther Adv Cardiovasc Dis. 2013 Aug;7(4):197-213. doi: 10.1177/1753944713487781. Epub 2013 Jul 1.

    PubMed 23818658

  • Yang J, Wu Y, Gao X, Bivard A, Levi CR, Parsons MW, Lin L; INSPIRE Study Groupdagger. Intraarterial Versus Intravenous Tirofiban as an Adjunct to Endovascular Thrombectomy for Acute Ischemic Stroke. Stroke. 2020 Oct;51(10):2925-2933. doi: 10.1161/STROKEAHA.120.029994. Epub 2020 Sep 16.

    PubMed 32933416

  • Yang M, Huo X, Gao F, Wang A, Ma N, Shi H, Chen W, Wang S, Wang Y, Miao Z. Low-dose rescue tirofiban in mechanical thrombectomy for acute cerebral large-artery occlusion. Eur J Neurol. 2020 Jun;27(6):1056-1061. doi: 10.1111/ene.14170. Epub 2020 Mar 17.

    PubMed 32048389

  • Neuberger U, Seker F, Schonenberger S, Nagel S, Ringleb PA, Bendszus M, Pfaff JAR, Mohlenbruch MA. Prediction of intracranial hemorrhages after mechanical thrombectomy of basilar artery occlusion. J Neurointerv Surg. 2019 Dec;11(12):1181-1186. doi: 10.1136/neurintsurg-2019-014939. Epub 2019 Jun 1.

    PubMed 31154353

  • Wu Y, Yin C, Yang J, Jiang L, Parsons MW, Lin L. Endovascular Thrombectomy. Stroke. 2018 Nov;49(11):2783-2785. doi: 10.1161/STROKEAHA.118.022919.

    PubMed 30355186

  • Guo Y, Lin Y, Tang Y, Tang Q, Wang X, Pan X, Zou J, Yang J. Safety and efficacy of early antiplatelet therapy in acute ischemic stroke patients receiving endovascular treatment: A systematic review and meta-analysis. J Clin Neurosci. 2019 Aug;66:45-50. doi: 10.1016/j.jocn.2019.05.028. Epub 2019 May 29.

    PubMed 31153752

  • Zhou J, Gao Y, Ma QL. Safety and efficacy of tirofiban in acute ischemic stroke patients not receiving endovascular treatment: a systematic review and meta-analysis. Eur Rev Med Pharmacol Sci. 2020 Feb;24(3):1492-1503. doi: 10.26355/eurrev_202002_20208.

    PubMed 32096199

  • Sun Y, Guo ZN, Yan X, Wang M, Zhang P, Qin H, Wang Y, Zhu H, Yang Y. Safety and efficacy of tirofiban combined with endovascular therapy compared with endovascular therapy alone in acute ischemic stroke: a meta-analysis. Neuroradiology. 2021 Jan;63(1):17-25. doi: 10.1007/s00234-020-02530-9. Epub 2020 Aug 25.

    PubMed 32844236

  • Lin L, Liu F, Yi T, Zhu Y, Yang J, Zhao Y, Wang F, Xiang G, Chen C, Xiao Y, Shen H, Xu L, Long Y, Zhang Y, Huang Z, Chen C, Churilov L, Parsons MW, Chen W, Li G; OPTIMISTIC Investigators. Tirofiban on First-Pass Recanalization in Acute Stroke Endovascular Thrombectomy: The OPTIMISTIC Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e255308. doi: 10.1001/jamanetworkopen.2025.5308.

    PubMed 40244586

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intravenous tirofiban combination therapy in people with Ischemic Stroke, run by Shanghai East Hospital at 1 site in China.

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 6 inclusion and 10 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: finished, as of the sponsor's last update on 9 Jan 2024. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Composite rates of target vessel revascularization and no symptomatic intracerebral haemorrhage (time frame: 24-72hours after thrombectomy;). 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 NCT04851457, which also lists 15 linked publications.

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 9 Jan 2024.

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