18 and older, any sex, with Stroke, Acute or Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Modified Rankin Scale at 3 Months in Acute Stroke (AIS and ICH)Primary· 3 months
Clinical outcome (modified Rankin Scale) at 3 months in acute stroke patients (target diagnosis) (generalized ordinal logistic regression). The assessment will performed by two independent telephone or face-to-face assessors.
the mRS range from 0 to 6, with higher scores representing worse outcome (mRS 0, no symptoms; mRS 6, death)
If disagreement occurs the patient will be contacted by a third assessor (face-to-face or telephone) who is blinded to the intervention who will assess the level of dependency.
* If disagreement occurs between two telephone assessments - a third, and final, telep
Group
Value
95% CI
Remote Ischemic Conditioning (RIC)
2
1 – 3
Sham
1
1 – 3
Difference Neurological Impairment During the First 24 HoursSecondary· 24 hours
Neurological deficits are documented using Prehospital Stroke Score (PreSS). Prehospital Stroke Score is assessed in the the ambulance and at 24-hour or at discharge (if discharge occurs before 24 hours). The PreSS score consists of the Cincinnati Prehospital Stroke Scale (CPSS) with an additional opportunity to report other neurological symptoms (e.g. ataxia, sensory disturbances and visual field loss), and PASS (Prehospital Acute Stroke Severity Scale). The PreSS score range from 0-6, with 6 representing the most severe neurological deficits.
Group
Value
95% CI
Remote Ischemic Conditioning
-1
-2 – 0
Sham - Remote Ischemic Conditioning
-2
-2 – 0
Clinical Outcome (Modified Rankin Scale (mRS) at 3 Months in Acute Ischemic StrokeSecondary· 3 months
Clinical outcome (modified Rankin Scale) at 3 months in acute stroke patients (target diagnosis) (generalized ordinal logistic regression). TThe assessment will performed by two independent telephone or face-to-face assessors.
the mRS range from 0 to 6, with higher scores representing worse outcome (mRS 0, no symptoms; mRS 6, death) If disagreement occurs the patient will be contacted by a third assessor (face-to-face or telephone) who is blinded to the intervention who will assess the level of dependency.
If disagreement occurs between two telephone assessments - a third, and final, telepho
Group
Value
95% CI
Remote Ischemic Conditioning (RIC)
1
1 – 2
Sham
1
0 – 3
Clinical Outcome (Modified Rankin Scale (mRS) at 3 Months in Acute Ischemic Stroke Receiving Reperfusion TherapySecondary· 3 months
Clinical outcome (modified Rankin Scale) at 3 months inacute ischemic stroke receiving reperfusion therapy (generalized ordinal logistic regression). The assessment will performed by two independent telephone or face-to-face assessors.
the mRS range from 0 to 6, with higher scores representing worse outcome (mRS 0, no symptoms; mRS 6, death) If disagreement occurs the patient will be contacted by a third assessor (face-to-face or telephone) who is blinded to the intervention who will assess the level of dependency.
If disagreement occurs between two telephone assessments - a third, and final
Group
Value
95% CI
Remote Ischemic Conditioning (RIC)
1
1 – 3
Sham
1
1 – 3
Clinical Outcome (Modified Rankin Scale (mRS) at 3 Months in Patients With Intracerebral Hemorrhage (ICH)Secondary· 3 months
Clinical outcome (modified Rankin Scale) at 3 months in patients with intracerebral hemorrhage (ICH) (generalized ordinal logistic regression).
The assessment will performed by two independent telephone or face-to-face assessors.
the mRS range from 0 to 6, with higher scores representing worse outcome (mRS 0, no symptoms; mRS 6, death) If disagreement occurs the patient will be contacted by a third assessor (face-to-face or telephone) who is blinded to the intervention who will assess the level of dependency.
If disagreement occurs between two telephone assessments - a third, and final, tel
Group
Value
95% CI
Remote Ischemic Conditioning (RIC)
3
2 – 5
Sham
3
2 – 5
Difference in Proportion of Patients With Complete Remission of Symptoms Within 24 Hours (TIA; Both With and Without DWI)Secondary· 3 months
Difference in proportion of patients with complete remission of symptoms within 24 hours (TIA; both with and without DWI) Diagnosis of TIA is documented in the electronic case report form
Group
Value
95% CI
Remote Ischemic Conditioning (RIC)
96
Sham
90
Major Adverse Cardiac and Cerebral Events (MACCE)Secondary· 3 months
MACCE is defined as: Cardiovascular events (cardiovascular death, myocardial infarction, acute ischemic or hemorrhagic stroke)
Cardiovascular death: Death from known cardiovascular cause or sudden death from unknown cause (no identified cause of death in medical history and/or autopsy)
Acute myocardial infarction: Admission with a discharge diagnosis of ST-elevation myocardial infarction (STEMI) and non-ST elevation myocardial infarction (NSTEMI) and unstable angina pectoris (UAP)
Stroke: Admission with a discharge diagnosis of acute ischemic or hemorrhagic stroke. Evaluation is performed u
Group
Value
95% CI
Remote Ischemic Conditioning (RIC)
57
Sham
62
Early Neurological Improvement in Acute Ischemic Stroke Patients (AIS)Secondary· 24 hours
Reduction in National Institute of Health Stroke Scale (NIHSS) ≥ 4 (baseline versus 24-Hour NIHSS). NIHSS range from 0 to 42, with higher scores representing worse neurological function.
Group
Value
95% CI
Remote Ischemic Conditioning (RIC)
108
Sham
131
Adverse events — posted to ClinicalTrials.gov
Time frame: 90 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Remote Ischemic Conditioning (RIC)
Serious: 335/713 (47%)
Deaths: 41/713
Sham
Serious: 325/720 (45%)
Deaths: 47/720
Serious adverse events (1 terms)
Reaction
System
Remote Ischemic Conditioni…
Sham
SAE
Cardiac disorders
—
—
Other adverse events (1 terms — click to expand)
Reaction
System
Remote Ischemic Conditioni…
Sham
Upper extremity pain during treatment and/or skin petechia
Our primary aim is to investigate whether remote ischemic conditioning (RIC) as an adjunctive treatment can improve long-term recovery in acute stroke patients as an adjunct to standard treatment.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07531394 — Safety and Efficacy of Remote Ischemic Conditioning in Patients With Acute Myocardial Injury Following Acute Ischemic St
· Phase 3
· not yet recruiting
NCT06082583 — The Efficacy of Combination of Traditional Tibetan and Remote Ischemic Conditioning on High Altitude Polycythemia
· Phase 2, PHASE3
· unknown
NCT05653505 — Remote Ischemic Conditioning Combined With Endovascular Stenting for Symptomatic Intracranial Atherosclerotic Stenosis
· not yet recruiting
NCT05379218 — RIC in HIE: A Safety and Feasibility Trial
· NA
· completed
NCT04659460 — RIC as an Adjunct Therapy for Severe COVID-19 Disease: a Prospective Randomized Pilot Study
· NA
· unknown
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· NA
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Other Grethe Andersen trials
Trials by the same sponsor.
NCT04266639 — Rheo-Erythrocrine Dysfunction as a Biomarker for RIC Treatment in Acute Ischemic Stroke
· NA
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Grethe Andersen
Last refreshed: 27 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/NCT03481777.