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NCT06301412: COTTIS-2
Combination of Hypothermia and Thrombectomy in Acute Stroke
Phase 3 trial testing hypothermia in Ischemic Stroke in 400 participants. Currently enrolling.
18 March 2026
Quick facts
| Lead sponsor | University of Freiburg |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 400 |
| Start date | 7 July 2024 |
| Primary completion | 18 March 2026 |
| Estimated completion | 18 June 2026 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- hypothermia
Conditions studied
- Ischemic Stroke — all drugs for Ischemic Stroke →
- Large Vessel Occlusion — all drugs for Large Vessel Occlusion →
- Endovascular Treatment — all drugs for Endovascular Treatment →
Sponsor
University of Freiburg
Who can join
18 and older, any sex, with Ischemic Stroke or Large Vessel Occlusion. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to test the combination of hypothermia and endovascular treatment in acute stroke patients with large vessel occlusion. The main question it aims to answer is: does an additional cooling to 35°C result in a benefit on clinical outcome ? Participants receive immediate cooling using a noninvasive transnasal cooling technique (RhonoChill) and are maintained at 35°C for 6 hours after reopening of the vessel using surface cooling, and then slowly rewarmed. Researchers will compare the intervention group (hypothermia and endovascular treatment and best medical treatment including iv thrombolysis) and control group (only endovascular treatment and best medical treatment including iv thrombolysis) to see if additional hypothermia leads to a better outcome after 3 months without relevant complications.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06301412
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of hypothermia
Trials testing the same drug.
- NCT06665386 — Prognostic Biomarkers for Selective Intra-Arterial Cooling Infusion Combined with Endovascular Thrombectomy in Acute Isc · recruiting
- NCT06109376 — Role of Hypothermia in Endovascular Stroke Thrombectomy · NA · not yet recruiting
- NCT02244034 — Incidence and Risk Factors of Postoperative Hypothermia in Cardiac Surgery · completed
Other recruiting trials for Ischemic Stroke
Currently open trials in the same condition.
- NCT07509645 — Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Post · Phase 3 · recruiting
- NCT07375953 — Repeated Intravenous Thrombolysis for Ischemic Stroke Within 3.0 Hours of Onset With Tenecteplase (RITIS-TNK) · Phase 2 · recruiting
- NCT07375966 — Repeated Intravenous Thrombolysis for Ischemic Stroke With Medium to Large Vessel Occlusion Presenting Within 4.5 Hours · Phase 2 · recruiting
- NCT07491952 — Continuous Dual Aspiration Technique With Zoom System for Stroke · recruiting
- NCT07371455 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants · Phase 1 · recruiting
Other University of Freiburg trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06301412 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Freiburg
- Last refreshed: 6 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06301412.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing