Contact information
Type
Scientific
Primary contact
Dr Jose Jr Nevado
ORCID ID
Contact details
1148 Orani Street
Malinta
Valenzuela City
1440
Philippines
+63 (0)2 4433711
jolnev2000@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
FINEST
Study hypothesis
Homocysteine is a sulphur-containing amino acid derived from the demethylation of methionine. Increased plasma homocysteine level has been recognised as a risk factor for cardiovascular diseases. Non-ST Elevation Myocardial Infarction (NSTEMI) and Unstable Angina (UA) belong to the spectrum of Acute Coronary Syndromes (ACS) that implies partial occlusion of the coronaries leading to ischaemic events. Unstable angina and NSTEMI have high recurrence rates for ACS and mortality six months after the event. Blood homocysteine levels are higher in patients with unstable angina, and it has been implicated to poorer outcomes and greater myocardial injury. Low homocysteine level confers better long-term outcomes among patients with coronary heart disease.
Folic acid is a potent homocysteine-lowering agent. It is used in several clinical trials to assess reduction of outcomes in subjects with cardiovascular disease.
Hypothesis:
Homocysteine-lowering could reduce subsequent clinical events, such as mortality and the composite outcomes of mortality, nonfatal acute coronary syndrome and other serious re-hospitalisation in people with UA or NSTEMI.
Ethics approval
Committee on Research Implementation and Development (CRID) (presently Research Implementation and Development Office [RIDO]) of the College of Medicine, University of the Philippines Manila, approved on October 25, 2002.
Study design
The study is a randomised placebo-controlled trial. The participants are recruited from five medical centres. The participants, researchers and assessors were blinded to treatment assignment.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Acute Coronary Syndromes (ACS)
Intervention
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 supplement for six months
The participants were followed up for six months.
Intervention type
Supplement
Phase
Not Specified
Drug names
Folic acid, vitamin B12, vitamin B6
Primary outcome measure
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 outcome measures
No secondary outcome measures
Overall trial start date
15/08/2003
Overall trial end date
15/08/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
250
Participant 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
Recruitment start date
15/08/2003
Recruitment end date
15/08/2006
Locations
Countries of recruitment
Philippines
Trial participating centre
1148 Orani Street
Valenzuela City
1440
Philippines
Sponsor information
Organisation
Philippine Council for Health Research and Development (PCHRD) (Philippines)
Sponsor details
3rd Floor
Department of Science and Technology (DOST)
Main Building
General Santos Avenue
Bicutan
Taguig City
1631
Philippines
+63 (0)2 8377535
gigi@pchrd.dost.gov.ph
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Department of Science and Technology (Philippines) - Grants in Aid program (DOST-GIA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19515873
Publication citations
-
Results
Imasa MS, Gomez NT, Nevado JB, Folic acid-based intervention in non-ST elevation acute coronary syndromes., Asian Cardiovasc Thorac Ann, 2009, 17, 1, 13-21, doi: 10.1177/0218492309102494.