Ignite Creation Date:
2024-05-05 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00794885
Status:
COMPLETED
Last Update Posted:
2014-08-12
First Post:
2008-11-19
Brief Title:
China Stroke Primary Prevention Trial
Sponsor:
Shenzhen Ausa Pharmed CoLtd
Organization:
Shenzhen Ausa Pharmed CoLtd
Study Overview
Official Title:
Enalapril Maleate and Folic Acid Tablets for Primary Prevention of Stroke in Patients With Hypertension a Post-marketing Double-blind Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CSPPT
Brief Summary:
The purpose of this trial is to confirm that enalapril maleate and folic acid tablets is more effective in preventing stroke among the patients with primary hypertension when compared to enalapril maleate
Detailed Description:
Primary hypertension is the most important risk factor leading to cardiovascular events Successful management of hypertension is a key to prevent these events Hyperhomocysteinemia HHcy is another independent risk factor especially for stroke Our teams prospective nested case-control study of 39165 subjects in China showed that incidence of cardiovascular events especially stroke was strongly associated with plasma level of total homocysteine tHcy The coexistence of hypertension and HHcy dramatically increased the risk of stroke by 25 to 30 times as compared to the subjects without the two risk factors Graham et al 1997 Findings from previous and our studies clearly indicate that simultaneous control of hypertension and HHcy is pivotal in reducing cardiovascular events morbidity and mortality in China
It has been well documented that folic acid is effective in lowering the level of plasma tHcy While controversial remains on its efficacy on preventing cardiovascular events a study done by our team Efficacy of folic acid supplementation in stroke prevention a meta-analysis Wang et al 2007 provide coherent evidence that folic acid supplementation can decrease the risk of stroke by 18 and 25 in populations where folic fortification was not issued or used for primary prevention
C677T gene polymorphism of 510-methylenetetrahydrofolate reductase MTHFR is one of the genetic determinators of plasma tHcy level Observational studies showed that individuals with TT genotype tend to have high plasma tHcy and elevated risk of cardiovascular events Cronin et al 2005 and folic acid supplementation led to a remarkable reduction in plasma tHcy In short previous studies by others and by our team have provided strong rationale for our proposed trial as detailed below
The hypothesis of the current study is that a combination of antihypertensive drug eg enalapril with folic acid is not only efficacious but also is safe and highly cost-effective than antihypertensive eg enalapril used alone to prevent stroke in hypertensive patients
This trial will enroll 20000 patients with primary hypertension and with known MTHFR C677T genotype Subjects will be first stratified by genotypes and then randomly assigned to treatment groups The study patients will be instructed to take orally enalapril 10 mg daily or enalaprilfolic acid 10mg08mg tablets daily for a maximum of 5 years The follow-up is given every 3 months
The incidence and time of first-time stroke episode primary endpoint or composite cardiovascular events are used as endpoints They will be compared by treatment groups with and without stratification by C677T gene polymorphisms The potential interaction between treatment groups and C677T gene polymorphisms on therapeutic efficacy will also be tested
This will be the first and largest trial of this kind in Chinese population The findings from this trial may have the potential to transform current clinical and public health findings into practice
It has been well documented that folic acid is effective in lowering the level of plasma tHcy While controversial remains on its efficacy on preventing cardiovascular events a study done by our team Efficacy of folic acid supplementation in stroke prevention a meta-analysis Wang et al 2007 provide coherent evidence that folic acid supplementation can decrease the risk of stroke by 18 and 25 in populations where folic fortification was not issued or used for primary prevention
C677T gene polymorphism of 510-methylenetetrahydrofolate reductase MTHFR is one of the genetic determinators of plasma tHcy level Observational studies showed that individuals with TT genotype tend to have high plasma tHcy and elevated risk of cardiovascular events Cronin et al 2005 and folic acid supplementation led to a remarkable reduction in plasma tHcy In short previous studies by others and by our team have provided strong rationale for our proposed trial as detailed below
The hypothesis of the current study is that a combination of antihypertensive drug eg enalapril with folic acid is not only efficacious but also is safe and highly cost-effective than antihypertensive eg enalapril used alone to prevent stroke in hypertensive patients
This trial will enroll 20000 patients with primary hypertension and with known MTHFR C677T genotype Subjects will be first stratified by genotypes and then randomly assigned to treatment groups The study patients will be instructed to take orally enalapril 10 mg daily or enalaprilfolic acid 10mg08mg tablets daily for a maximum of 5 years The follow-up is given every 3 months
The incidence and time of first-time stroke episode primary endpoint or composite cardiovascular events are used as endpoints They will be compared by treatment groups with and without stratification by C677T gene polymorphisms The potential interaction between treatment groups and C677T gene polymorphisms on therapeutic efficacy will also be tested
This will be the first and largest trial of this kind in Chinese population The findings from this trial may have the potential to transform current clinical and public health findings into practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None