NCT06373042: ADJUVANT-2

Tirofiban for Successful Endovascular Stroke Thrombectomy

Not yet recruiting Phase 2, PHASE3 Last updated 16 May 2024

What this trial tests

Phase 2, PHASE3 trial testing Intraarterial and intravenous tirofiban in Stroke, Acute Ischemic in 712 participants. Not yet recruiting.

Timeline

31 July 2024

Primary endpoint
31 July 2026

31 October 2026

Quick facts

Lead sponsor	Zhongming Qiu
Phase	Phase 2, PHASE3
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	712
Start date	31 July 2024
Primary completion	31 July 2026
Estimated completion	31 October 2026

Drugs / interventions tested

• Intraarterial and intravenous tirofiban — full drug profile →
• Intraarterial and intravenous placebo — full drug profile →

Conditions studied

• Stroke, Acute Ischemic — all drugs for Stroke, Acute Ischemic →

Sponsor

Zhongming Qiu — full company profile →

Who can join

18 and older, any sex, with Stroke, Acute Ischemic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.