EVALUATION OF TWO STRATEGIES IN SECONDARY PREVENTION OF STROKE/TIA: LDL-C LOWERING TO 100±10 MG/DL OR TO <70 MG/D, EXTENSION IN KOREA TRIA

Not Applicable

Terminated

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0004974
• Lead Sponsor: Asan Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-01-31
• Last Update Posted: 4 April 2023

Recruitment & Eligibility

• Status: Terminated
• Sex: All
• Target Recruitment: 714

Inclusion Criteria

The included patients were enrolled between late 2015 and December 2018, and fulfilled the following criteria:
1.patient with:
a.stabilize cerebral infarction previously enrolled in the TST trials
b.with ischemic stroke proven on MRI or head-CT regardless of the duration of the syptoms.
c.stabilize TIA previously enrolled in the TST trials
2. with documented atherosclerotic disease :
a. presence of extra-cranial carotid luminal stenosis (as diagnosed by carotid duplex or CT-angiography or MR-angiography, or X-ray angiography) on either side (i.e., not necessarely on the symptomatic side)
b. or presence of intra-cranial luminal stenosis (as diagnosed by trancranial Doppler or CT-angiography or MR-angiography, or X-ray angiography)
c. or presence of atherosclerotic luminal stenosis in another cerebral artery (vertebral, basilar or other intra-cranial artery stenosis) (as diagnosed with CT-angiography, MR-angiography of X-ray angiography)
d. or presence of atherosclerosis in the aortic arch (as diagnosed by transesophageal echocardiography or CT-angiography) ,regardless of the thickness of the aortic arch plaque
3. with a clinical indication of statin treatment according to country recommendation
4. age equal or above 20
6. with a Rankin score equal or less than 4
7. patient has signed an informed consent
8. Women of childbearing potential, should be on effective contraception

Exclusion Criteria

1. Ischemic stroke/TIA due to cerebral artery dissection (as documented following the judgment of the investigator) or to a cardiac source of embolism (as documented following the judgment of the investigator) without atherosclerotic disease being present (e.g., mitral stenosis, endomyocardial fibrosis). For example a patient with atrial fibrillation or a past history of myocardial infarction or an aortic stenosis would be elligible if he/she satisfies the above inclusion criteria.
2. Symptomatic brain hemorrhage (the mere presence of microbleeds on gradient echo imaging is not an exclusion criteria)
3. Uncontrolled hypertension (following the judgment of the lnvestigator)
4. patient for whom intensification of statin treatment is impossible.
5. Intercurrent or concomittant disease that precludes a follow-up visits or that can interfere with endpoints evaluation.
6. Intercurrent disease that may interfere with evaluation of the primary end-point or that may prevent follow-up study visits
7. Participation in another clinical trial.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite endpoint: ischemic stroke or undetermined stroke, myocardial infarction, urgent coronary revascularization following new symptoms, urgent carotid or cerebral artery revascularization following new TIA, vascular death including sudden death

Secondary Outcome Measures

Name	Time	Method
Individual component of the primary endpoint;Primary endpoint or intracranial hemorrhage;Intracranial hemorrhage;Newly diagnosed diabetes