Cardiovascular DiseasesPhase 3NCT00000482
Coronary Drug Project
A Phase 3 study testing estrogen, clofibrate clofibrate and dextrothyroxine sodium in people with Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine whether regular administration of lipid modifying drugs (clofibrate, nicotinic acid, estrogen, dextrothyroxine) to men with a documented myocardial infarction would result in significant reduction in total mortality over a five year period. Read more about this study
- Who is it for?
- Ages 30 to 64 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- What is being tested?
- estrogen, clofibrate clofibrate and dextrothyroxine sodium
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1965to Mar 1985
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 64 years
- Men only
- No healthy volunteers
- Adult
Men, ages 30-64. Three months beyond most recent myocardial infarction.
About this study
To determine whether regular administration of lipid modifying drugs (clofibrate, nicotinic acid, estrogen, dextrothyroxine) to men with a documented myocardial infarction would result in significant reduction in total mortality over a five year period. Secondarily, to determine whether the degree to which these drugs changed serum lipids was correlated with any effect on mortality and morbidity rates; to gain further information on the long-term prognosis of myocardial infarction (by studying the control group as intensively as the treatment group); to acquire further experience and knowledge concerning the techniques and methodology of long-term clinical trials; to determine, in a substudy, the effectiveness of aspirin, a platelet inhibitor, in reducing recurrences of myocardial infarction.
Read the detailed description
BACKGROUND:
Correlation of high levels of serum cholesterol with an increased incidence and prevalence of coronary heart disease (CHD) was demonstrated--prior to the inception of the Coronary Drug Project--repeatedly in prospective and cross-sectional epidemiological surveys (e.g., the Tecumseh Study, the Framingham Heart Disease Study). These findings led to the question of whether long-term lowering of serum lipids in individuals both with and without CHD would have a beneficial effect on morbidity and mortality.
The Coronary Drug Project was designed to answer the question of secondary prevention. In 1961, Dr. Robert Wilkins (Boston University School of Medicine) chaired an ad hoc committee which determined the desirability and feasibility of the conduct of this study. Following National Heart Advisory Council (NHAC) support, a study Policy Board, Steering Committee, and Coordinating Center were established and a detailed protocol was written.
In 1964, NHAC approved the project and the NHI recommendation for implementation; the study was begun in 1965. Supported by the grant mechanism, the trial involved 53 participating clinics, a coordinating center, central laboratory, ECG center, drug procurement and distribution center, and NHI medical liaison office, and a policy board, steering committee, and 12 other committees (e.g., a data and safety monitoring committee).
The first patient was randomly allocated to treatment in March 1966 and the last in October 1969. Each patient reported to the clinic every 4 months for a follow-up visit.
DESIGN NARRATIVE:
Randomized, double-blind, fixed sample. A total of 8,341 patients were randomly assigned to six treatment groups consisting of 2.5 mg/day of conjugated estrogens, 5.0 mg/day of conjugated estrogens, 1.8 gm/day of clofibrate, 6.0 mg/day of dextrothyroxine sodium, 3.0 gm/day of niacin, or 3.8 gm/day of lactose placebo.
The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Myocardial Ischemia
- Being tested
- estrogen, clofibrate clofibrate, dextrothyroxine sodium, niacin
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estrogenDrug
clofibrate clofibrateDrug
dextrothyroxine sodiumDrug
niacinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 1999 (estimated)
- Study startApr 1965
- Study completionMar 1985
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Paul Canner, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000482
- Sponsor's protocol ID
- 1
- Other IDs
- R01HL008888-14
- Status last verified
- Jul 2004
- First submitted
- 27 Oct 1999
- Last updated
- 26 Nov 2013
- Results posted
- No
Publications
Coronary Drug Project Enters Enrollment Phase (Medical News). JAMA, 200:37-38, l967.
Parsons, W. Coronary Drug Project Deserves Support of Nation's Physicians. Cardiology Digest, January l967, pp. l3-l6.
Coronary Drug Project, Publication l695. National Heart Institute, Public Health Service, l968.
Coronary Drug Project Research Group: Control of Hyperlipidemia: 4. Progress in Drug Trials of Secondary Prevention with Particular Reference to the Coronary Drug Project, in Jones, R.J. (ed), Atherosclerosis (Proceedings of the Second International Symposium). New York, Springer-Verlag, l970, pp. 586-595.
The Coronary Drug Project. Initial findings leading to modifications of its research protocol. JAMA. 1970 Nov 16;214(7):1303-13. No abstract available.
PubMed 4320008Heart Drug Project Yields Good Results (Medical News). JAMA, 2l3:954-956, l970.
The coronary drug project. Findings leading to further modifications of its protocol with respect to dextrothyroxine. The coronary drug project research group. JAMA. 1972 May 15;220(7):996-1008. No abstract available.
PubMed 4337170Coronary Drug Project Research Group: The Natural History of Myocardial Infarction in the Coronary Drug Project: Prognostic Indicators Following Infarction, in Tibblin, G., Keys, A., Werko, L. (eds), Preventive Cardiology, Stockholm, Almqvist & Wiksell, l972, pp. 54-64.
The prognostic importance of the electrocardiogram after myocardial infarction. Experience in the Coronary Drug Project. Ann Intern Med. 1972 Nov;77(5):677-89. doi: 10.7326/0003-4819-77-5-677. No abstract available.
PubMed 4117098The coronary drug project. Design, methods, and baseline results. Circulation. 1973 Mar;47(3 Suppl):I1-50. doi: 10.1161/01.cir.47.3s1.i-1. No abstract available.
PubMed 4570454Prognostic importance of premature beats following myocardial infarction. Experience in the coronary drug project. JAMA. 1973 Mar 5;223(10):1116-24. doi: 10.1001/jama.1973.03220100016005. No abstract available.
PubMed 4119817The Coronary Drug Project. Findings leading to discontinuation of the 2.5-mg day estrogen group. The coronary Drug Project Research Group. JAMA. 1973 Nov 5;226(6):652-7. No abstract available.
PubMed 4356847Left ventricular hypertrophy patterns and prognosis. Experience postinfarction in the Coronary Drug Project. Circulation. 1974 May;49(5):862-9. doi: 10.1161/01.cir.49.5.862. No abstract available.
PubMed 4275188Factors influencing long-term prognosis after recovery from myocardial infarction--three-year findings of the coronary drug project. J Chronic Dis. 1974 Aug;27(6):267-85. doi: 10.1016/0021-9681(74)90091-5. No abstract available.
PubMed 4610000The prognostic importance of premature ventricular complexes in the late post-infarction period. Experience in the Cornary Drug Project. Acta Cardiol. 1974;Suppl 18:33-53. No abstract available.
PubMed 4138758
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Drug Project
- ClinicalTrials.gov ID
- NCT00000482
- Acronym / sponsor ID
- 1
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Myocardial Ischemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Apr 1965
- Study completion
- Mar 1985 (actual)
- First posted
- 28 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether regular administration of lipid modifying drugs (clofibrate, nicotinic acid, estrogen, dextrothyroxine) to men with a documented myocardial infarction would result in significant reduction in total mortality over a five year period. Secondarily, to determine whether the degree to which these drugs changed serum lipids was correlated with any effect on mortality and morbidity rates; to gain further information on the long-term prognosis of myocardial infarction (by studying the control group as intensively as the treatment group); to acquire further experience and knowledge concerning the techniques and methodology of long-term clinical trials; to determine, in a substudy, the effectiveness of aspirin, a platelet inhibitor, in reducing recurrences of myocardial infarction.
Detailed description
BACKGROUND:
Correlation of high levels of serum cholesterol with an increased incidence and prevalence of coronary heart disease (CHD) was demonstrated--prior to the inception of the Coronary Drug Project--repeatedly in prospective and cross-sectional epidemiological surveys (e.g., the Tecumseh Study, the Framingham Heart Disease Study). These findings led to the question of whether long-term lowering of serum lipids in individuals both with and without CHD would have a beneficial effect on morbidity and mortality.
The Coronary Drug Project was designed to answer the question of secondary prevention. In 1961, Dr. Robert Wilkins (Boston University School of Medicine) chaired an ad hoc committee which determined the desirability and feasibility of the conduct of this study. Following National Heart Advisory Council (NHAC) support, a study Policy Board, Steering Committee, and Coordinating Center were established and a detailed protocol was written.
In 1964, NHAC approved the project and the NHI recommendation for implementation; the study was begun in 1965. Supported by the grant mechanism, the trial involved 53 participating clinics, a coordinating center, central laboratory, ECG center, drug procurement and distribution center, and NHI medical liaison office, and a policy board, steering committee, and 12 other committees (e.g., a data and safety monitoring committee).
The first patient was randomly allocated to treatment in March 1966 and the last in October 1969. Each patient reported to the clinic every 4 months for a follow-up visit.
DESIGN NARRATIVE:
Randomized, double-blind, fixed sample. A total of 8,341 patients were randomly assigned to six treatment groups consisting of 2.5 mg/day of conjugated estrogens, 5.0 mg/day of conjugated estrogens, 1.8 gm/day of clofibrate, 6.0 mg/day of dextrothyroxine sodium, 3.0 gm/day of niacin, or 3.8 gm/day of lactose placebo.
The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| estrogen | Drug | – |
| clofibrate clofibrate | Drug | – |
| dextrothyroxine sodium | Drug | – |
| niacin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
- BackgroundCoronary Drug Project Enters Enrollment Phase (Medical News). JAMA, 200:37-38, l967.
- BackgroundParsons, W. Coronary Drug Project Deserves Support of Nation's Physicians. Cardiology Digest, January l967, pp. l3-l6.
- BackgroundCoronary Drug Project, Publication l695. National Heart Institute, Public Health Service, l968.
- BackgroundCoronary Drug Project Research Group: Control of Hyperlipidemia: 4. Progress in Drug Trials of Secondary Prevention with Particular Reference to the Coronary Drug Project, in Jones, R.J. (ed), Atherosclerosis (Proceedings of the Second International Symposium). New York, Springer-Verlag, l970, pp. 586-595.
- Background: PubMed 4320008The Coronary Drug Project. Initial findings leading to modifications of its research protocol. JAMA. 1970 Nov 16;214(7):1303-13. No abstract available.
- BackgroundHeart Drug Project Yields Good Results (Medical News). JAMA, 2l3:954-956, l970.
- Background: PubMed 4337170The coronary drug project. Findings leading to further modifications of its protocol with respect to dextrothyroxine. The coronary drug project research group. JAMA. 1972 May 15;220(7):996-1008. No abstract available.
- BackgroundCoronary Drug Project Research Group: The Natural History of Myocardial Infarction in the Coronary Drug Project: Prognostic Indicators Following Infarction, in Tibblin, G., Keys, A., Werko, L. (eds), Preventive Cardiology, Stockholm, Almqvist & Wiksell, l972, pp. 54-64.
- Background: PubMed 4117098The prognostic importance of the electrocardiogram after myocardial infarction. Experience in the Coronary Drug Project. Ann Intern Med. 1972 Nov;77(5):677-89. doi: 10.7326/0003-4819-77-5-677. No abstract available.
- Background: PubMed 4570454The coronary drug project. Design, methods, and baseline results. Circulation. 1973 Mar;47(3 Suppl):I1-50. doi: 10.1161/01.cir.47.3s1.i-1. No abstract available.
- Background: PubMed 4119817Prognostic importance of premature beats following myocardial infarction. Experience in the coronary drug project. JAMA. 1973 Mar 5;223(10):1116-24. doi: 10.1001/jama.1973.03220100016005. No abstract available.
- Background: PubMed 4356847The Coronary Drug Project. Findings leading to discontinuation of the 2.5-mg day estrogen group. The coronary Drug Project Research Group. JAMA. 1973 Nov 5;226(6):652-7. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Canner
University of Maryland
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing estrogen, clofibrate clofibrate and dextrothyroxine sodium in people with Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000482, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2013.