Trial Outcomes & Findings for Trial to Assess Chelation Therapy (TACT) (NCT NCT00044213)
NCT ID: NCT00044213
Last Updated: 2013-11-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1708 participants
Primary outcome timeframe
Measured over a maximum 5-year follow-up period- 55 month median
Results posted on
2013-11-05
Participant Flow
The primary analysis of the trial included 1708 patients who had been enrolled from September 2003 through October 2011 (median, 55 months)Participants were recruited at 134 sites in the US and Canada.
Participant milestones
| Measure |
EDTA + High Dose Vitamin
Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
|
EDTA + High Dose Vitamin Placebo
Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
|
EDTA Placebo + High Dose Vitamin
Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
|
EDTA Placebo + High Dose Vitamin Placebo
Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
421
|
418
|
432
|
437
|
|
Overall Study
COMPLETED
|
321
|
306
|
294
|
301
|
|
Overall Study
NOT COMPLETED
|
100
|
112
|
138
|
136
|
Reasons for withdrawal
| Measure |
EDTA + High Dose Vitamin
Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
|
EDTA + High Dose Vitamin Placebo
Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
|
EDTA Placebo + High Dose Vitamin
Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
|
EDTA Placebo + High Dose Vitamin Placebo
Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
50
|
65
|
91
|
83
|
|
Overall Study
Death
|
42
|
42
|
42
|
49
|
|
Overall Study
Lost to Follow-up
|
8
|
5
|
5
|
4
|
Baseline Characteristics
Trial to Assess Chelation Therapy (TACT)
Baseline characteristics by cohort
| Measure |
EDTA + High Dose Vitamin
n=421 Participants
Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
|
EDTA + High Dose Vitamin Placebo
n=418 Participants
Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
|
EDTA Placebo + High Dose Vitamin
n=432 Participants
Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
|
EDTA Placebo + High Dose Vitamin Placebo
n=437 Participants
Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
|
Total
n=1708 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
65 Years
n=5 Participants
|
65 Years
n=7 Participants
|
66 Years
n=5 Participants
|
66 Years
n=4 Participants
|
65.5 Years
n=21 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
299 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
351 Participants
n=5 Participants
|
336 Participants
n=7 Participants
|
355 Participants
n=5 Participants
|
367 Participants
n=4 Participants
|
1409 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Measured over a maximum 5-year follow-up period- 55 month medianNumber 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.
Outcome measures
| Measure |
EDTA + High Dose Vitamin
n=421 Participants
Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
|
EDTA + High Dose Vitamin Placebo
n=418 Participants
Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
|
EDTA Placebo + High Dose Vitamin
n=432 Participants
Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
|
EDTA Placebo + High Dose Vitamin Placebo
n=437 Participants
Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
|
|---|---|---|---|---|
|
A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina.
|
108 participants
|
114 participants
|
122 participants
|
139 participants
|
SECONDARY outcome
Timeframe: Measured over a maximum 5-year follow-up period- 55 month medianNumber 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.
Outcome measures
| Measure |
EDTA + High Dose Vitamin
n=421 Participants
Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
|
EDTA + High Dose Vitamin Placebo
n=418 Participants
Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
|
EDTA Placebo + High Dose Vitamin
n=432 Participants
Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
|
EDTA Placebo + High Dose Vitamin Placebo
n=437 Participants
Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
|
|---|---|---|---|---|
|
A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke.
|
39 participants
|
57 participants
|
55 participants
|
58 participants
|
Adverse Events
EDTA + High Dose Vitamin
Serious events: 2 serious events
Other events: 168 other events
Deaths: 0 deaths
EDTA + High Dose Vitamin Placebo
Serious events: 0 serious events
Other events: 201 other events
Deaths: 0 deaths
EDTA Placebo + High Dose Vitamin
Serious events: 0 serious events
Other events: 164 other events
Deaths: 0 deaths
EDTA Placebo + High Dose Vitamin Placebo
Serious events: 2 serious events
Other events: 185 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EDTA + High Dose Vitamin
n=421 participants at risk
Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
|
EDTA + High Dose Vitamin Placebo
n=418 participants at risk
Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
|
EDTA Placebo + High Dose Vitamin
n=432 participants at risk
Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
|
EDTA Placebo + High Dose Vitamin Placebo
n=437 participants at risk
Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
|
|---|---|---|---|---|
|
General disorders
Malaise
|
0.24%
1/421 • Number of events 1
|
0.00%
0/418
|
0.00%
0/432
|
0.00%
0/437
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.24%
1/421 • Number of events 1
|
0.00%
0/418
|
0.00%
0/432
|
0.00%
0/437
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/421
|
0.00%
0/418
|
0.00%
0/432
|
0.46%
2/437 • Number of events 2
|
Other adverse events
| Measure |
EDTA + High Dose Vitamin
n=421 participants at risk
Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
|
EDTA + High Dose Vitamin Placebo
n=418 participants at risk
Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
|
EDTA Placebo + High Dose Vitamin
n=432 participants at risk
Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
|
EDTA Placebo + High Dose Vitamin Placebo
n=437 participants at risk
Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.6%
15/421
|
3.8%
16/418
|
5.3%
23/432
|
5.3%
23/437
|
|
Gastrointestinal disorders
Nausea
|
4.0%
17/421
|
5.3%
22/418
|
3.7%
16/432
|
4.3%
19/437
|
|
Investigations
White Blood Cell Count Decreased
|
3.1%
13/421
|
6.5%
27/418
|
3.7%
16/432
|
4.3%
19/437
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
15.0%
63/421
|
16.5%
69/418
|
7.9%
34/432
|
9.8%
43/437
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
9.5%
40/421
|
11.5%
48/418
|
11.3%
49/432
|
12.4%
54/437
|
|
Renal and urinary disorders
Proteinuria
|
4.8%
20/421
|
4.5%
19/418
|
6.0%
26/432
|
6.2%
27/437
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Enrolling Centers must abide by all TACT and NIH conflict of interest policies. Decisions about authorship on all multi-center publications resulting from research under this agreement will be made by the TACT Publica¬tions Committee prior to publication. No publications or other public disclosure shall be made until the TACT results are unblinded and results from all sites have been received and analyzed or TACT has been abandoned at all sites.
- Publication restrictions are in place
Restriction type: OTHER