Acute Coronary Syndromes (ACS) Circulatory System Coronary Diseases
Conditions
Interventions
Active group (116 participants): A once daily oral supplement of 1 mg folic acid, 400 µg vitamin B12, and 10 mg vitamin B6 for six months
Placebo group (124 participants): Once daily oral placebo supp
Sponsors
Philippine Council for Health Research and Development (PCHRD) (Philippines)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects with unstable angina (intermediate- and high-risk) or NSTEMI with an onset in the past two weeks were screened for inclusion for the study. Participants should be more than 18 years of age upon inclusion, either male or female.
Exclusion criteria
Exclusion criteria: The exclusion criteria include the following: 1. Haemodynamic instability (cardiogenic shock, ongoing chest pain, unresolved and new onset end-organ damage, and unstable congestive heart failure in the past two weeks) 2. Significant liver disease (classical signs and symptoms, or three times the upper limit of normal in liver enzymes, or a deranged Prothrombin Time [PT] 1.5 x normal not explained by anticoagulant intake) 3. Significant renal disease (with creatinine levels more than 180 µmol/dl or requiring dialysis) 4. Haemoglobin less than 1 g/dl 5. High output failure 6. Could not provide adequate self-care 7. Malignancy or any terminal illness 8. Pregnancy 10. Could not provide independent informed consent 11. Living outside Metro Manila or the adjacent provinces of Cavite and Rizal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. All-cause mortality 2. Composite outcomes of mortality, nonfatal acute coronary syndromes and serious rehospitalisation Outcomes measured every six months for three years, timepoints were as follows: 31st January 2004 31st July 2004 31st January 2005 31st July 2005 31st January 2006 31st July 2006 | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Philippines
Outcome results
None listed