China Stroke Secondary Prevention Trial

• Status: Withdrawn
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The CSSPT study is a multi-center, randomized, double blinded, placebo-controlled secondary stroke prevention trial in China to determine whether the addition of folic acid and vitamin supplements will reduce recurrent stroke events and other combined incidence of recurrent vascular events and vascular death.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xijing Hospital
• Treatments: Folic Acid; Hydroxocobalamin; Pyridoxal; Pyridoxine; Vitamin B 12; Vitamin B 6; Vitamin B Complex; Vitamins

Criteria

Inclusion Criteria:

• Patients presenting within one months of ischemic stroke (ischemic or hemorrhagic) or TIA

• Homocysteine level ≥ 15μmol／L

• Agree to take study medication;Be geographically accessible for follow-up

• Provide written informed consent

Exclusion Criteria:

• Other cause of ischemic stroke (cardioembolism; stroke of other determined etiology, and stroke of undetermined etiology according to TOAST subtypes) or hemorrhagic stroke (intracranial vascular malformations; cerebral amyloid angiopathy; trauma and bleeding disorders etc)

• Use of vitamin supplements containing folate, B6 or B12

• Pregnancy or women of child-bearing potential who are at risk of pregnancy

• Limited life expectancy