Exploratory Study on the Effects of Early Rosuvastatin Treatment in Patients With Acute Ischemic Stroke

NCT02643784 | Unknown Phase 4 DMC

• 1 other identifier: ESR-14-10028
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an exploratory, randomized, open-label, 2-arm, parallel-group study exploring the efficacy of rosuvastatin (20mg/day) in patients with acute ischemic stroke.

Conditions

Ischemic

Keywords

acute ischemic stroke

Outcome Measures

Primary Outcomes (1)

• Percent changes in infarction volumes measured by MRI on the 14th day compared with the baseline of the stroke

  0-14d

Secondary Outcomes (5)

• Absolute changes in infarction volumes measured by MRI on the 14th day compared with the baseline of the stroke

  0-14d

• Proportion of patients whose infarction volume reduced on the 14th day compared with the baseline of the stroke

  0-14d

• The neurological outcomes measured by NIHSS (14,90 days), compared between statin group and standard group

  14-90d

• The functional outcome measured by modified Rankin Scale (14,90 days), compared between statin group and standard group

  14-90d

• The rate of the new-onset infarct assessed by MRI from baseline to 14th day, compared between statin group and standard group

  0-14d

Study Arms (2)

Rosuvastatin

EXPERIMENTAL

Rosuvastatin study drug will be supplied in tablets (10 mg), assigned dose to be taken orally, once daily by subjects randomized to receive rosuvastatin 20 mg(take rosuvastatin until 14th day).

Drug: Rosuvastatin; Other: Control

Control

NO INTERVENTION

Control group(don't take rosuvastatin until 14th day), as directed by the study physician.

Interventions

Rosuvastatin DRUG

Randomized Treatment Period (Day 1 through Day 14): 20 mg once daily for 14 days. Follow up Period (Day 15 through Day 90) Subjects in both groups who enter the follow up period will receive rosuvastatin 10mg/day.

Also known as: RSV

Rosuvastatin

Control OTHER

Randomized Treatment Period (Day 1 through Day 14): No treatment of rosuvastatin for control group. Follow up Period (Day 15 through Day 90) Subjects in both groups who enter the follow up period will receive rosuvastatin 10mg/day.

Rosuvastatin

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 75 years old patients;
• Stroke involving the vascular territory of the middle cerebral artery (MCA) as judged by clinical and MRI evidences;
• Time from symptom onset to take the study assigned medication is within 24 hours;
• Statin naïve or discontinued at least 3 month before stroke onset;
• First ever stroke or mild sequelae (with modified Rankin Score 0-1) before the index event;
• Moderate neurological deficit with baseline NIHSS scoring from 4-20;
• MRI scans （T1W1、T2W2、T2Flair、DWI、SWI）accomplished from 12 to 48 hours after the onset;
• Consent form signed.

You may not qualify if:

• Stroke involving the vascular territory of the vertebrobasilar artery as judged by clinical and MRI evidences;
• Any circumstances under which MRI scans can't be performed;
• Evidences suggesting cardiogenic stroke such as atrial fibrillation, acute coronary syndrome, patent foramen ovale , etc;
• Comatose with NIHSS 1a\>1;
• Medical or psychiatric conditions such as severe hepatic or renal dysfunction, heart failure, malignancy, major depression, dementia, alcohol or drug abuse;
• Suitable for rt-Plasminogen Activator thrombolysis treatment;
• Receiving medication with possible neuroprotective functions after stroke onset;
• Currently take steroids therapy;
• Diagnosed with malignancy within 5 years;
• Patients with myopathy or serum creatine kinase \> 3 times the upper limit of normal not caused by myocardial injury;
• Severe renal function damage (eGFR\<30);
• Concurrent use ciclosporin;
• A history of hypersensitivity of statins and other severe complication;
• Child-bearing women ;
• Patients who are or may be pregnant;

Sponsors & Collaborators

• RenJi Hospital: lead

MeSH Terms

Conditions

Ischemia; Ischemic Stroke

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 31, 2015
• Study Start: December 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: December 31, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will share