Folate Intervention in Non-ST elevation myocardial infarction and unstable angina: a randomised placebo-controlled trial
| ISRCTN | ISRCTN30249553 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30249553 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/06/2007
- Registration date
- 30/07/2007
- Last edited
- 06/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jose Jr Nevado
Scientific
Scientific
1148 Orani Street
Malinta
Valenzuela City
1440
Philippines
| Phone | +63 (0)2 4433711 |
|---|---|
| jolnev2000@yahoo.com |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | FINEST |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 15/08/2003 |
| Completion date | 15/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 250 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 15/08/2003 |
| Date of final enrolment | 15/08/2006 |
Locations
Countries of recruitment
- Philippines
Study participating centre
1148 Orani Street
Valenzuela City
1440
Philippines
1440
Philippines
Sponsor information
Philippine Council for Health Research and Development (PCHRD) (Philippines)
Government
Government
3rd Floor
Department of Science and Technology (DOST)
Main Building
General Santos Avenue
Bicutan
Taguig City
1631
Philippines
| Phone | +63 (0)2 8377535 |
|---|---|
| gigi@pchrd.dost.gov.ph | |
| Website | http://www.pchrd.dost.gov.ph |
Funders
Funder type
Government
The Department of Science and Technology (Philippines) - Grants in Aid program (DOST-GIA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2009 | Yes | No |
