Safety and Tolerability of AZD6482 in Reperfusion for Stroke

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

STARS is a prospective, multicentre, open-label, dose escalation, Phase IIa study to assess the safety and tolerability of AZD6482, an adjuvant antiplatelet therapy, in patients with AIS.

Acute ischaemic stroke (AIS) is caused by a severe blockage of an artery leading to immediate reduced blood flow to part of the brain. Standard therapies target the blocked artery by either dissolving the blockage or removing the blockage. However, even after successful treatment, re-blockage of arteries can occur. The use of an antiplatelet therapy, AZD6482, in addition to standard therapies offers the possibility of improved restoration of blood flow and reduced rates of artery re-blockage.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The George Institute
• Collaborator: Heart Research Institute

Criteria

Inclusion Criteria

1. Patient aged 18 years or more

2. Patient has an acute ischaemic stroke (AIS)

3. Patient will be treated with either:

1. Intravenous thrombolysis (IVT) with alteplase or tenecteplase for a diagnosis of AIS that is confirmed by CT perfusion imaging;

alone/OR WITH

2. Endovascular Thrombectomy (EVT) for LVO in the internal carotid artery, proximal middle cerebral artery (M1 segment), proximal M2 or with tandem occlusion of both the cervical carotid and intracranial large arteries who either:

i. presented within 6 hours of stroke onset

OR

ii. presented between 6-24 hours after they were last known to be well and clinical observations and either CT perfusion or MRI features indicate the presence of salvageable brain tissue, defined as ischaemic core <70mL with a mismatch ratio >1.8 and absolute mismatch >15mL.

4. Patient has at least a mild grade of neurological impairment (NIHSS >4)

5. Patient has an estimated pre-stroke mRS of less than 4

Exclusion Criteria

1. Patient is considered unlikely to benefit from study intervention defined by one of the following:

1. Advanced dementia

2. Severe pre-stroke disability (mRS score 4-5)

3. Glasgow Coma Score (GCS) 3 to 5

4. Evidence of a large well-defined ischaemic lesion measuring more than one third of the MCA territory

2. Platelet count <100,000/uL

3. INR >1.7

4. Uncontrolled hypertension (SBP >180 or DBP >110, refractory to medical therapy)

5. ICH within the last 90 days

6. Myocardial infarction or stroke within the last 30 days

7. Patient has an underlying disease process with a life expectancy of <90 days

8. Contraindication to thrombolysis i.e. increased bleeding risk

9. Contraindication to intravenous contrast agents including renal impairment or allergy

10. Known treatment with dual antiplatelet therapy or anticoagulant medication

11. Known severe liver disease

12. Known bleeding disorder

13. Cardiopulmonary resuscitation or arterial puncture at non-compressible site or lumbar puncture within 7 days

14. Another medical illness or social circumstance that may interfere with outcome assessments and follow-up

15. Known or suspected pregnancy

16. Patients currently participating in another interventional clinical trial

17. Informed consent unable to be obtained from the patient or their Person Responsible/Medical Treatment Decision Maker prior to study interventions