Coronary Artery DiseasePhase 3NCT00044213
Trial to Assess Chelation Therapy (TACT)
A Phase 3 study testing EDTA and High Dose Vitamin in people with Coronary Artery Disease, run by Mt. Sinai Medical Center, Miami at 86 sites in 2 countries.
Trial summary
The purpose of this study is to determine the safety and effectiveness of ethylene diamine tetra-acetic (EDTA) chelation therapy in individuals with coronary artery disease. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- EDTA and High Dose Vitamin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,708 participants
- Where
- 86 sitesin 2 countries
- Study dates
- Sep 2003to Aug 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart attack at least 6 weeks prior to study start
Who cannot join
- Serum creatinie level greater than 2.0 mg/dL
- Platelet count less than 100,000/µL
- Blood pressure greater than 160/100
- Chelation therapy within 5 years prior to study start
- History of allergic reactions to EDTA or any of the therapy's components
- Coronary or carotid revascularization procedures within 6 months prior to study start or a scheduled revascularization
Show all 12Show fewer
- Cigarette smoking within 3 months prior to study start
- Childbearing potential
- History of liver disease
- Active heart failure or heart failure hospitalization within 6 months.
- Diagnoses of additional medical conditions that could otherwise limit patient survival
- Inability to tolerate 500-mL infusions weekly.
Trial locations and contacts
86 sites in 2 countries.
86 sites in 2 countries
United States73 sites
Athens Surgery Clinic
Athens, Tennessee, 37303
Emory University School of Medicine
Atlanta, Georgia, 30303
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
St. Charles Health System
Bend, Oregon, 97701
Celebration of Health Center
Bluffton, Ohio, 45817
The Blend Institute
Bradenton, Florida, 34221
Wellness Works
Brandon, Florida, 33510
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
Marino Center for Progressive Health
Cambridge, Massachusetts, 02140
Magaziner Center for Wellness
Cherry Hill, New Jersey, 08003
Innovative Research of West Florida
Clearwater, Florida, 33756
University Hospitals of Cleveland
Cleveland, Ohio, 44106
University of Missouri Hospital and Clinics
Columbia, Missouri, 65201
The Ohio State University Medical Center
Columbus, Ohio, 43210
Mt Holistic Health Center
Danville, California, 94526
Aurora Denver Cardiology Associates
Denver, Colorado, 80218
Henry Ford Health System Preventative Cardiology Clay Ford Center for Athletic Medicine
Detroit, Michigan, 48202
Heart Care Center
East Syracuse, New York, 13057
The Cardiovascular Group
Fairfax, Virginia, 22031
The Preventive Medicine Center
Flint, Michigan, 48503
Full Circle Medical Center
Fort Oglethorpe, Georgia, 30742
Hyperbaric Medicine Inc.
Fort Walton Beach, Florida, 32547
White-Wilson Medical Center
Fort Walton Beach, Florida, 32547
Patrick A. Golden
Fresno, California, 93720
Crossroads Healing Arts LLC
Goshen, Indiana, 46528
Born Preventive Health Care Clinic
Grand Rapids, Michigan, 49512
Wholistic Health Center
Greensburg, Pennsylvania, 15601
Brian Dieterle, MD, PhD
Hollister, Missouri, 65673
The Castle Clinic, PLLC
Johnson City, Tennessee, 37601
Parchment Family Practice
Kalamazoo, Michigan, 49004
Kansas University Medical Center
Kansas City, Kansas, 66160
Scripps Center for Integrative Medicine
La Jolla, California, 92037
Biogenesis Medical Center
Landrum, South Carolina, 29356
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Complementary Medical Services
Mandeville, Louisiana, 70471
The Gables Natural Medicines Center & Day Spa Family Health Services
Mayville, New York, 14757
Tru Med
Melbourne, Florida, 32901
Baptist Cardiac & Vascular Institute
Miami, Florida, 33176
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Berman Center for Outcomes and Clinical Research
Minneapolis, Minnesota, 55404
Tri-Health Alternative Medical Center
Mt. Dora, Florida, 32757
Phoenix Wellness Group
Napa, California, 94558
NYU School of Medicine
New York, New York, 10016
COR Research
Oklahoma City, Oklahoma, 73103
Maine Integrative Wellness
Portland, Maine, 04103
Center for Environmental Medicine
Portland, Oregon, 97220
Freedom Center for Advanced Medicine
Provo, Utah, 84604
Woodlands Healing Research Center
Quakertown, Pennsylvania, 18951
Rhinebeck Health Center
Rhinebeck, New York, 12572
Mayo Clinic and Foundation Cardiovascular Health Clinic
Rochester, Minnesota, 55905
Park Professional Building
Roselle Park, New Jersey, 07204
Heart and Vascular Center for Research, Inc.
Sarasota, Florida, 34239
Integrative Medical Center at Schneck Medical Center
Seymour, Indiana, 47274
Preventive Medicine
St Louis, Missouri, 63146
Staten Island Heart
Staten Island, New York, 10305
Stockton Family Practice
Stockton, New Jersey, 08559
Schachter Center for Complementary Medicine
Suffern, New York, 10901
Florida Cardiovascular Institute
Tampa, Florida, 33609
Chelation Centers of Texas
Texas City, Texas, 77591
Bronx-Lebanon Hospital Center
The Bronx, New York, 10457
Life Family Practice Center for Complementary and Alternative Medicine
The Villages, Florida, 32159
Comprehensive Heart Care, Inc.
Toledo, Ohio, 43606
Upper Valley Family Care
Troy, Ohio, 45373
Integrative Medical Associates, PLLC
Tryon, North Carolina, 28782
Northwest Indiana Cardiovascular Physicians Inc.
Valparaiso, Indiana, 46383
Hope Medical Holistic Clinic
Vancouver, Washington, 98663
Virginia Beach General Hospital
Virginia Beach, Virginia, 23454
Care Foundation Inc.
Wausau, Wisconsin, 54401
The Center for the Improvement of Functioning International
Wichita, Kansas, 67219
Waters Preventive Medical Center, LTD
Wisconsin Dells, Wisconsin, 53965
Main Line Health Heart Center
Wynnewood, Pennsylvania, 19096
Florida Medical Clinic, P.A. Clinical Research Division
Zephyrhills, Florida, 33542
Canada13 sites
Chelation Center of Barrie, Inc.
Barrie, Ontario, L4N9T6
Anti-Aging & Family Wellness Clinic
Madoc, Ontario, K0K 2K0
Markham Integrative Medicine
Markham, Ontario, L3P 1Y8
Cline Medical Centre
Nanaimo, British Columbia, V9R 2M9
North Bay Complementary
North Bay, Ontario, P1B 4B8
Seekers Centre for Integrative Medicine
Ottawa, Ontario, K2E 1B3
The Wellness Centre
Port Hawkesbury, Nova Scotia, V4P 1B5
Saskatoon Chelation Centre
Saskatoon, Saskatchewan, S7M 5W1
Dr. C. Minielly
Smith Falls, Ontario, K7A 1C3
Chelation Center of Don Valley Inc.
Toronto, Ontario, M3C3F2
Jaconello Health Centre
Toronto, Ontario, M4K 3T1
Chelation and Natural Therapy
Toronto, Ontario, M4W 3T1
Chelox
Toronto, Ontario, M6H 3M2
About this study
The purpose of this study is to determine the safety and effectiveness of ethylene diamine tetra-acetic (EDTA) chelation therapy in individuals with coronary artery disease.
Read the detailed description
EDTA chelation therapy involves repeated administrations of a synthetic amino acid to reduce atherosclerotic plaque and other mineral deposits throughout the cardiovascular system.
Participants will be randomly assigned to receive 40 infusions of either the standard chelation solution or placebo. The primary endpoint of this trial will be a composite of all cause mortality, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina.
The results of TACT will provide either a significant positive result or an informative null result upon which rational clinical decision-making and health policy can be based.
- Conditions
- Coronary Artery Disease
- Being tested
- EDTA, EDTA Placebo, High Dose Vitamin, High Dose Vitamin Placebo
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDTADrug
Participants will receive 40 infusions of standard chelation solution.
EDTA PlaceboDrug
Participants will receive 40 infusions of EDTA placebo.
High Dose VitaminDietary supplement
High Dose Vitamin PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| EDTA + high dose vitamin | Active comparator | Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins. Receives: Drug: EDTA; Dietary Supplement: High Dose Vitamin |
| EDTA + high dose vitamin placebo | Placebo comparator | Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins. Receives: Drug: EDTA; Dietary Supplement: High Dose Vitamin Placebo |
| EDTA placebo + high dose vitamin | Placebo comparator | Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins. Receives: Drug: EDTA Placebo; Dietary Supplement: High Dose Vitamin |
| EDTA placebo + high dose vitamin placebo | Placebo comparator | Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins. Receives: Drug: EDTA Placebo; Dietary Supplement: High Dose Vitamin Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina.
Number of patients with events (composite of death from any cause, MI, stroke, coronary revascularization or hospitalization for angina) Events were centrally adjudicated where available; otherwise site reported events were used.
Measured: Measured over a maximum 5-year follow-up period- 55 month median
Secondary outcomes (1)
A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke.
Number of patients with events (composite of cardiovascular death, non-fatal MI, non-fatal stroke) Events were centrally adjudicated where available; otherwise site reported events were used.
Measured: Measured over a maximum 5-year follow-up period- 55 month median
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2002 (estimated)
- Study startSep 2003
- Primary completionOct 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,708 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mt. Sinai Medical Center, Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Gervasio Lamas, MD, Mt. Sinai Medical Center, Miami
- Investigators
- Gervasio A Lamas, M.D., Study director, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044213
- Sponsor's protocol ID
- 654
- Other IDs
- U01HL092607, U01AT001156
- Status last verified
- Aug 2013
- First submitted
- 22 Aug 2002
- Last updated
- 5 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Escolar E, Ujueta F, Kim H, Mark DB, Boineau R, Nahin RL, Goertz C, Lee KL, Anstrom KJ, Lamas GA. Possible differential benefits of edetate disodium in post-myocardial infarction patients with diabetes treated with different hypoglycemic strategies in the Trial to Assess Chelation Therapy (TACT). J Diabetes Complications. 2020 Aug;34(8):107616. doi: 10.1016/j.jdiacomp.2020.107616. Epub 2020 May 7.
PubMed 32446881Mark DB, Anstrom KJ, Clapp-Channing NE, Knight JD, Boineau R, Goertz C, Rozema TC, Liu DM, Nahin RL, Rosenberg Y, Drisko J, Lee KL, Lamas GA; TACT Investigators. Quality-of-life outcomes with a disodium EDTA chelation regimen for coronary disease: results from the trial to assess chelation therapy randomized trial. Circ Cardiovasc Qual Outcomes. 2014 Jul;7(4):508-16. doi: 10.1161/CIRCOUTCOMES.114.000977.
PubMed 24987051Lamas GA, Boineau R, Goertz C, Mark DB, Rosenberg Y, Stylianou M, Rozema T, Nahin RL, Lindblad L, Lewis EF, Drisko J, Lee KL; TACT (Trial to Assess Chelation Therapy) Investigators. Oral high-dose multivitamins and minerals after myocardial infarction: a randomized trial. Ann Intern Med. 2013 Dec 17;159(12):797-805. doi: 10.7326/0003-4819-159-12-201312170-00004.
PubMed 24490264Escolar E, Lamas GA, Mark DB, Boineau R, Goertz C, Rosenberg Y, Nahin RL, Ouyang P, Rozema T, Magaziner A, Nahas R, Lewis EF, Lindblad L, Lee KL. The effect of an EDTA-based chelation regimen on patients with diabetes mellitus and prior myocardial infarction in the Trial to Assess Chelation Therapy (TACT). Circ Cardiovasc Qual Outcomes. 2014 Jan;7(1):15-24. doi: 10.1161/CIRCOUTCOMES.113.000663. Epub 2013 Nov 19.
PubMed 24254885Lamas GA, Goertz C, Boineau R, Mark DB, Rozema T, Nahin RL, Lindblad L, Lewis EF, Drisko J, Lee KL; TACT Investigators. Effect of disodium EDTA chelation regimen on cardiovascular events in patients with previous myocardial infarction: the TACT randomized trial. JAMA. 2013 Mar 27;309(12):1241-50. doi: 10.1001/jama.2013.2107.
PubMed 23532240Lamas GA, Goertz C, Boineau R, Mark DB, Rozema T, Nahin RL, Drisko JA, Lee KL. Design of the Trial to Assess Chelation Therapy (TACT). Am Heart J. 2012 Jan;163(1):7-12. doi: 10.1016/j.ahj.2011.10.002.
PubMed 22172430
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial to Assess Chelation Therapy (TACT)
- ClinicalTrials.gov ID
- NCT00044213
- Acronym / sponsor ID
- 654
- Conditions
- Coronary Artery Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,708 participants (actual)
- Lead sponsor
- Mt. Sinai Medical Center, MiamiUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Sep 2003
- Primary completion
- Oct 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 23 Aug 2002 (estimated)
- Results
- Posted 5 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and effectiveness of ethylene diamine tetra-acetic (EDTA) chelation therapy in individuals with coronary artery disease.
Detailed description
EDTA chelation therapy involves repeated administrations of a synthetic amino acid to reduce atherosclerotic plaque and other mineral deposits throughout the cardiovascular system.
Participants will be randomly assigned to receive 40 infusions of either the standard chelation solution or placebo. The primary endpoint of this trial will be a composite of all cause mortality, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina.
The results of TACT will provide either a significant positive result or an informative null result upon which rational clinical decision-making and health policy can be based.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EDTA + high dose vitamin | Active comparator | Drug: EDTA, Dietary Supplement: High Dose VitaminParticipants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins. |
| EDTA + high dose vitamin placebo | Placebo comparator | Drug: EDTA, Dietary Supplement: High Dose Vitamin PlaceboParticipants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins. |
| EDTA placebo + high dose vitamin | Placebo comparator | Drug: EDTA Placebo, Dietary Supplement: High Dose VitaminParticipants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins. |
| EDTA placebo + high dose vitamin placebo | Placebo comparator | Drug: EDTA Placebo, Dietary Supplement: High Dose Vitamin PlaceboParticipants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Heart attack at least 6 weeks prior to study start
Key exclusion criteria (12 listed)
- Serum creatinie level greater than 2.0 mg/dL
- Platelet count less than 100,000/µL
- Blood pressure greater than 160/100
- Chelation therapy within 5 years prior to study start
- History of allergic reactions to EDTA or any of the therapy's components
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 |
|---|---|---|
| EDTAParticipants will receive 40 infusions of standard chelation solution. | Drug | EDTA + high dose vitamin, EDTA + high dose vitamin placebo |
| EDTA PlaceboParticipants will receive 40 infusions of EDTA placebo. | Drug | EDTA placebo + high dose vitamin, EDTA placebo + high dose vitamin placebo |
| High Dose Vitamin | Dietary supplement | EDTA + high dose vitamin, EDTA placebo + high dose vitamin |
| High Dose Vitamin Placebo | Dietary supplement | EDTA + high dose vitamin placebo, EDTA placebo + high dose vitamin placebo |
Primary outcome
A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina.
Time frame: Measured over a maximum 5-year follow-up period- 55 month median
Number of patients with events (composite of death from any cause, MI, stroke, coronary revascularization or hospitalization for angina) Events were centrally adjudicated where available; otherwise site reported events were used.
1 secondary outcome
A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke.
Time frame: Measured over a maximum 5-year follow-up period- 55 month median
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32446881Escolar E, Ujueta F, Kim H, Mark DB, Boineau R, Nahin RL, Goertz C, Lee KL, Anstrom KJ, Lamas GA. Possible differential benefits of edetate disodium in post-myocardial infarction patients with diabetes treated with different hypoglycemic strategies in the Trial to Assess Chelation Therapy (TACT). J Diabetes Complications. 2020 Aug;34(8):107616. doi: 10.1016/j.jdiacomp.2020.107616. Epub 2020 May 7.
- Derived from this study: PubMed 24987051Mark DB, Anstrom KJ, Clapp-Channing NE, Knight JD, Boineau R, Goertz C, Rozema TC, Liu DM, Nahin RL, Rosenberg Y, Drisko J, Lee KL, Lamas GA; TACT Investigators. Quality-of-life outcomes with a disodium EDTA chelation regimen for coronary disease: results from the trial to assess chelation therapy randomized trial. Circ Cardiovasc Qual Outcomes. 2014 Jul;7(4):508-16. doi: 10.1161/CIRCOUTCOMES.114.000977.
- Derived from this study: PubMed 24490264Lamas GA, Boineau R, Goertz C, Mark DB, Rosenberg Y, Stylianou M, Rozema T, Nahin RL, Lindblad L, Lewis EF, Drisko J, Lee KL; TACT (Trial to Assess Chelation Therapy) Investigators. Oral high-dose multivitamins and minerals after myocardial infarction: a randomized trial. Ann Intern Med. 2013 Dec 17;159(12):797-805. doi: 10.7326/0003-4819-159-12-201312170-00004.
- Derived from this study: PubMed 24254885Escolar E, Lamas GA, Mark DB, Boineau R, Goertz C, Rosenberg Y, Nahin RL, Ouyang P, Rozema T, Magaziner A, Nahas R, Lewis EF, Lindblad L, Lee KL. The effect of an EDTA-based chelation regimen on patients with diabetes mellitus and prior myocardial infarction in the Trial to Assess Chelation Therapy (TACT). Circ Cardiovasc Qual Outcomes. 2014 Jan;7(1):15-24. doi: 10.1161/CIRCOUTCOMES.113.000663. Epub 2013 Nov 19.
- Derived from this study: PubMed 23532240Lamas GA, Goertz C, Boineau R, Mark DB, Rozema T, Nahin RL, Lindblad L, Lewis EF, Drisko J, Lee KL; TACT Investigators. Effect of disodium EDTA chelation regimen on cardiovascular events in patients with previous myocardial infarction: the TACT randomized trial. JAMA. 2013 Mar 27;309(12):1241-50. doi: 10.1001/jama.2013.2107.
- Derived from this study: PubMed 22172430Lamas GA, Goertz C, Boineau R, Mark DB, Rozema T, Nahin RL, Drisko JA, Lee KL. Design of the Trial to Assess Chelation Therapy (TACT). Am Heart J. 2012 Jan;163(1):7-12. doi: 10.1016/j.ahj.2011.10.002.
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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.
Gervasio A Lamas, M.D. study director
Icahn School of Medicine at Mount Sinai
86 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EDTA and High Dose Vitamin in people with Coronary Artery Disease, run by Mt. Sinai Medical Center, Miami at 86 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. 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 5 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 86 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 5 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina. (time frame: Measured over a maximum 5-year follow-up period- 55 month median). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00044213, which also lists 6 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 5 Nov 2013.