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

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ClinicalTrials.gov Identifier: NCT02643784
Recruitment Status : Unknown
Verified December 2015 by RenJi Hospital.
Recruitment status was:  Not yet recruiting
First Posted : December 31, 2015
Last Update Posted : December 31, 2015
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

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.

Condition or disease Intervention/treatment Phase
Ischemic Drug: Rosuvastatin Other: Control Phase 4

Detailed Description:
This is a 90-day, explanatory; randomized; open-label, 2-arm; parallel group with blinded outcome evaluation study exploring the efficacy and study of early rosuvastatin 20 mg/d treatment in acute ischemic patients with stroke onset in 24 hours.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploratory Study on the Effects of Early Rosuvastatin Treatment in Patients With Acute Ischemic Stroke
Study Start Date : December 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rosuvastatin
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

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.

Other Name: RSV

Other: Control

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.


No Intervention: Control
Control group(don't take rosuvastatin until 14th day), as directed by the study physician.



Primary Outcome Measures :
  1. Percent changes in infarction volumes measured by MRI on the 14th day compared with the baseline of the stroke [ Time Frame: 0-14d ]

Secondary Outcome Measures :
  1. Absolute changes in infarction volumes measured by MRI on the 14th day compared with the baseline of the stroke [ Time Frame: 0-14d ]
  2. Proportion of patients whose infarction volume reduced on the 14th day compared with the baseline of the stroke [ Time Frame: 0-14d ]
  3. The neurological outcomes measured by NIHSS (14,90 days), compared between statin group and standard group [ Time Frame: 14-90d ]
  4. The functional outcome measured by modified Rankin Scale (14,90 days), compared between statin group and standard group [ Time Frame: 14-90d ]
  5. The rate of the new-onset infarct assessed by MRI from baseline to 14th day, compared between statin group and standard group [ Time Frame: 0-14d ]


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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 45 to 75 years old patients;
  2. Stroke involving the vascular territory of the middle cerebral artery (MCA) as judged by clinical and MRI evidences;
  3. Time from symptom onset to take the study assigned medication is within 24 hours;
  4. Statin naïve or discontinued at least 3 month before stroke onset;
  5. First ever stroke or mild sequelae (with modified Rankin Score 0-1) before the index event;
  6. Moderate neurological deficit with baseline NIHSS scoring from 4-20;
  7. MRI scans (T1W1、T2W2、T2Flair、DWI、SWI)accomplished from 12 to 48 hours after the onset;
  8. Consent form signed.

Exclusion Criteria:

-

Any of the following is regarded as a criterion for exclusion from the study:

  1. Stroke involving the vascular territory of the vertebrobasilar artery as judged by clinical and MRI evidences;
  2. Hemorrhagic transformation or intracranial hemorrhage on baseline MRI. MRI performed between 12-48 hours after the onset, if MRI provides evidences which met with the exclusion criteria, the patients will be excluded from the study;
  3. Any circumstances under which MRI scans can't be performed;
  4. Evidences suggesting cardiogenic stroke such as atrial fibrillation, acute coronary syndrome, patent foramen ovale , etc;
  5. Comatose with NIHSS 1a>1;
  6. Medical or psychiatric conditions such as severe hepatic or renal dysfunction, heart failure, malignancy, major depression, dementia, alcohol or drug abuse;
  7. Suitable for rt-Plasminogen Activator thrombolysis treatment;
  8. Receiving medication with possible neuroprotective functions after stroke onset;
  9. Currently take steroids therapy;
  10. Diagnosed with malignancy within 5 years;
  11. Patients with myopathy or serum creatine kinase > 3 times the upper limit of normal not caused by myocardial injury;
  12. Severe renal function damage (eGFR<30);
  13. Concurrent use ciclosporin;
  14. A history of hypersensitivity of statins and other severe complication;
  15. Child-bearing women ;
  16. Patients who are or may be pregnant;
  17. Other conditions under which patients not pertinent to attend the study as judged by the investigators.

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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT02643784     History of Changes
Other Study ID Numbers: ESR-14-10028
First Posted: December 31, 2015    Key Record Dates
Last Update Posted: December 31, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by RenJi Hospital:
acute ischemic stroke
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors