Tirofiban for Successful Endovascular Stroke Thrombectomy

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhongming Qiu

About this trial

Up to 50% of acute ischemic stroke patients with large vessel occlusion failed to achieve functional independence even after successful reperfusion therapy, a phenomenon that is referred to as "futile recanalization". The mechanism of futile recanalization is complex, and some studies have shown that it may be related to factors such as tissue no reflow, reocclusion, poor status of collateral circulation, hemorrhagic transformation, impaired cerebrovascular autonomic regulation, and low perfusion volume. Several studies suggested that maximizing the improvement of cerebral reperfusion is still the primary goal of acute large vessel occlusive stroke. Structural and functional alterations in the microvascular system may be a major obstacle to reperfusion. In animal models of cerebral ischemia, downstream microvascular thrombosis may occur in the early stage of cerebral ischemia and before vascular recanalization, which is the main factor leading to incomplete reperfusion and affecting the efficacy of endovascular thrombectomy.

Mechanical thrombectomy mainly addressed the occluded large arteries, and does not consider the distal arteries. However, the recanalization of occluded large arteries does not necessarily translate into successful reperfusion of the ischemic tissue supplied by the distal capillaries. Even with complete recanalization, impaired microcirculatory reperfusion may lead to poor clinical outcomes. Therefore, we speculate that at the end of endovascular thrombectomy, microthrombi remain present in the microcirculation of brain tissue in patients with complete or near-complete cerebral angiography, and that microthrombi is more likely to be dissolved than thrombus more proximal to the heart. Therefore, intra-arterial administration of pharmaceutical, such as tirofiban, may be the only possible option to ensure complete reperfusion of ischemic tissue. Tirofiban is a platelet glycoprotein IIb/IIIa receptor antagonist, which has been widely used in acute coronary syndrome, and its role in acute ischemic stroke has attracted more and more attention from stroke experts. Previous studies have suggested that tirofiban can further increase the incidence of successful recanalization, while reducing the reocclusion rate.

Whether early administration of intraarterial and intravenous tirofiban can further improve the clinical outcomes of patients with large vessel occlusive stroke after successful mechanical thrombectomy remains unclear.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical inclusion criteria

Aged 18 years or older;

Acute ischemic stroke within 24 hours from last known well to randomization;

NIHSS score ≥6 and <30 points at baseline;

Disqualifiers

Cardiogenic embolism;

Patient receive tirofiban for angioplasty/stenting prior to randomization;

Intracranial hemorrhage confirmed by flat panel CT on angiography machine prior to randomization;

Patients who are on prior anticoagulant therapy, e.g. for deep venous thrombosis or pulmonary embolism or mechanical heart valve;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intraarterial and intravenous tirofiban

    Drug

    Intraarterial and intravenous tirofiban after endovascular thrombectomy

  • Intraarterial and intravenous placebo

    Drug

    Intraarterial and intravenous placebo after endovascular thrombectomy

Treatment groups

712 Participants
are divided into 2 treatment groups
Group A: TirofibanExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Functional independence

modified Rankin scale score of 0 to 2. (The modified Rankin scale scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)

Time frame
90 days post-randomization

Secondary outcomes

1

Recanalization on follow-up CTA or MRA

Measured with the arterial occlusive lesion (AOL) scale

Time frame
within 48 hours post-randomization
2

Early neurologic improvement

defined as NIHSS score at 48 hours after randomization is reduced by 8 or more compared to NIHSS score at randomization; or the NIHSS at 48 hours after randomization is 0 to 1

Time frame
within 48 hours post-randomization
3

Level of disability

Measured with the mRS

Time frame
90 days post-randomization
4

Excellent outcome

defined as mRS score of 0-1

Time frame
90 days post-randomization

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhongming Qiu

Lead sponsor

Xinqiao Hospital of Chongqing

Sponsor institution

Mianyang Central Hospital

Collaborator

The Second Affiliated Hospital of Chongqing Medical University

Collaborator

The Second Hospital of Jiaozuo

Collaborator

Chongzhou People's Hospital

Collaborator

Xihua People's Hospital

Collaborator

Xingguo People's Hospital

Collaborator

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