Authorised Phase I and Phase II (Integrated)- Other Acute Ischemic Stroke

Evaluation of Novel Thrombolytic TGD001 in Patients With Acute Ischemic Stroke

EU CTIS ID: 2025-522455-26-00

What this study is testing

To assess the safety and tolerability of single intravenous (IV) doses of TGD001 in participants with an acute ischemic stroke (AIS) diagnosis, supported by neuroimaging, who either 1) receive endovascular thrombectomy (EVT), or 2) do not receive EVT or standard of care (SOC) intravenous thrombolysis (IVT).

  • Phase I and Phase II (Integrated)- Other

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Age ≥18 and <80 years
  • Functionally independent (mRS 0-2) prior to stroke onset
  • Diagnosis of AIS supported by neuroimaging: a visible occlusion and/or an ischemic lesion (ASPECTS 6 - 10) with target mismatch
  • Baseline NIHSS ≥5 and that remains ≥5 immediately before enrollment
  • Participants who A) meet the local EVT eligibility requirements and undergo EVT or B) do not receive EVT or SOC IVT.

You likely can't join if

  • Intracranial hemorrhage on pre-intervention imaging
  • Demarcated infarct or early ischemic changes resulting in an Alberta stroke program early CT score (ASPECTS) ≤5 on pre-intervention imaging
  • Use of an anticoagulant, including but not limited to direct oral anticoagulants (DOAC) or warfarin, within the last 48 hours or recent oral anticoagulant therapy with an international normalized ratio (INR) ≥1.7.

The study team makes the final eligibility decision.

Where it's taking place

  • Serbia

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Serbia. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.