Condition category
Circulatory System
Date applied
26/06/2007
Date assigned
30/07/2007
Last edited
06/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.pchrd.dost.gov.ph

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19515873

Publication citations

  1. 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.

Additional files

Editorial Notes