Cangrelor in endovascular stroke treatment with emergent carotid artery stenting (CANCAS)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Graz

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

6 Nov 2025 → ongoing

Decision date (initial)

2025-10-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

VASCage GmbH · Chiesi Pharmaceuticals GmbH

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

To assess the safety and efficacy of IV Cangrelor in patients with acute ischaemic stroke and large vessel occlusion of the intracranial carotid artery or first two segments of the middle cerebral artery (carotid artery territory) and concomitant symptomatic atherosclerotic extracranial carotid artery stenosis (≥50%) requiring mechanical thrombectomy and emergent extracranial carotid artery stenting.

Secondary objectives 1

1. Successful cerebral reperfusion according to the modified thrombolysis in cerebral infarction (mTICI) scales 2b-315 on angiography at the end of endovascular stroke treatment after stent placement

Conditions and MedDRA coding

ischemic stroke with intracranial large artery occlusion of the anterior cerebral circulation

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Adult patients (≥18 years of age)
2. Large vessel occlusion stroke of the anterior cerebral circulation (carotid artery territory)
3. Concomitant ipsilateral atherosclerotic carotid artery stenosis ≥50% requiring mechanical thrombectomy and emergent carotid artery stenting

Exclusion criteria 9

1. Non-atherosclerotic carotid artery stenosis (e.g. dissection)
2. Active pre-treatment with a P2Y12 inhibitor (e.g. Clopidogrel, Ticagrelor, Prasugrel
3. Pre-treatment with oral anticoagulants in a therapeutic dosage
4. Known pregnancy (for women with childbearing potential a negative pregnancy test is required)
5. High intra- or extracranial bleeding risk according to the judgement of the treating stroke physicians (history of severe bleeding disorders, known haemophilia, severe liver disease, thrombocytopenia <100,000/µL, coagulation factor abnormalities, recent major surgery, recent major trauma, large brain infarct size
6. Uncontrolled hypertension
7. The patient’s medical history reveals a known allergy to any of the medications being used or their constituents, or to medications with a similar chemical structure
8. Prohibited concomitant therapies
9. Simultaneous participation in another interventional clinical trial

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Carotid artery stent patency at 24 (+/-6) hours after stenting

Secondary endpoints 7

1. Successful cerebral reperfusion according to modified Thrombolysis In Cerebral Infarction (mTICI) scores 2b-3
2. Clinical stroke severity according to the National Institutes Health Stroke Scale score at 24 (±6) hours and discharge from hospital or day 7
3. Modified Rankin Scale score at 90 (±14) days after stroke (telephone assessment allowed)
4. Symptomatic intracranial haemorrhage (ECASS III definition)
5. Major bleeding according to ISTH definition
6. Intracranial haemorrhage PH1, PH2, class 3 according to Heidelberg Bleeding Classification
7. In-hospital mortality

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 2

Auxiliary 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Graz

Sponsor organisation

Medical University Of Graz

Address

Neue Stiftingtalstrasse 6

City

Graz

Postcode

8010

Country

Austria

Scientific contact point

Organisation

Medical University Of Graz

Contact name

Lisa Jaritz

Public contact point

Organisation

Medical University Of Graz

Contact name

Lisa Jaritz

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications