Trial · NCT00433966

Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction

NCT00433966, Phase 3, Completed, Cardiovascular Research Foundation, New York; results first posted 2017-12-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction. Trials, record NCT00433966. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00433966

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction
NCT number: NCT00433966
Status: Completed
Phases: Phase 3
Enrollment: 3,602 participants, actual
Lead sponsor: Cardiovascular Research Foundation, New York
Conditions: Myocardial Infarction
Interventions: Bivalirudin, Unfractionated heparin, Bare metal stent, Paclitaxel-eluting stent
First posted: 2007-02-12
Last updated: 2017-12-04
Results first posted: 2017-12-04

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events	30 Days	Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke) and major bleeding (bleeding adjudicated as not related to coronary artery bypass grafting).
Primary	Stent Arm - Ischemic Target Lesion Revascularization	1 year	Number of Participants With Ischemic Target Lesion Revascularization
Primary	Stent Arm - Death, Reinfarction, Stroke, or Stent Thrombosis	1 year	Number of Participants With Death, Reinfarction, Stroke, or Stent Thrombosis
Secondary	Pharmacology Arm - Major Adverse Cardiovascular Events	30 days	Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke)
Secondary	Pharmacology Arm - Non-Coronary Artery Bypass Grafting-Related Major Bleeding	30 days	Number of participants with major bleeding (bleeding adjudicated as not related to coronary artery bypass grafting)
Secondary	Stent Arm - Segment Binary Angiographic Restenosis	13 months	Number of Participants With Segment Binary Angiographic Restenosis (13-month Angiographic Subset).
Secondary	Pharmacology Arm - Major Adverse Cardiovascular Events	3 years	Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke)

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events	30 Days	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Stent Arm - Ischemic Target Lesion Revascularization	1 year	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Stent Arm - Death, Reinfarction, Stroke, or Stent Thrombosis	1 year	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Pharmacology Arm - Major Adverse Cardiovascular Events	30 days	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Pharmacology Arm - Non-Coronary Artery Bypass Grafting-Related Major Bleeding	30 days	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Stent Arm - Segment Binary Angiographic Restenosis	13 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Pharmacology Arm - Major Adverse Cardiovascular Events	3 years	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events	Pharmacology Arm - Bivalirudin	166	Participants
Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events	Pharmacology Arm - Unfractionated Heparin	218	Participants
Stent Arm - Ischemic Target Lesion Revascularization	Stent Arm - Paclitaxel-Eluting Stent	98	Participants
Stent Arm - Ischemic Target Lesion Revascularization	Stent Arm - Bare Metal Stent	54	Participants
Stent Arm - Death, Reinfarction, Stroke, or Stent Thrombosis	Stent Arm - Paclitaxel-Eluting Stent	181	Participants
Stent Arm - Death, Reinfarction, Stroke, or Stent Thrombosis	Stent Arm - Bare Metal Stent	59	Participants
Pharmacology Arm - Major Adverse Cardiovascular Events	Pharmacology Arm - Bivalirudin	98	Participants
Pharmacology Arm - Major Adverse Cardiovascular Events	Pharmacology Arm - Unfractionated Heparin	99	Participants
Pharmacology Arm - Non-Coronary Artery Bypass Grafting-Related Major Bleeding	Pharmacology Arm - Bivalirudin	89	Participants
Pharmacology Arm - Non-Coronary Artery Bypass Grafting-Related Major Bleeding	Pharmacology Arm - Unfractionated Heparin	149	Participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow44

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Pharmacology Intervention/Randomization	STARTED	Pharmacology Arm - Bivalirudin	1,800
Pharmacology Intervention/Randomization	STARTED	Pharmacology Arm - Unfractionated Heparin	1,802
Pharmacology Intervention/Randomization	STARTED	Stent Arm - Paclitaxel-Eluting Stent	0
Pharmacology Intervention/Randomization	STARTED	Stent Arm - Bare Metal Stent	0
Pharmacology Intervention/Randomization	30-Day Follow-up	Pharmacology Arm - Bivalirudin	1,787
Pharmacology Intervention/Randomization	30-Day Follow-up	Pharmacology Arm - Unfractionated Heparin	1,791
Pharmacology Intervention/Randomization	30-Day Follow-up	Stent Arm - Paclitaxel-Eluting Stent	0
Pharmacology Intervention/Randomization	30-Day Follow-up	Stent Arm - Bare Metal Stent	0
Pharmacology Intervention/Randomization	1-Year Follow-up	Pharmacology Arm - Bivalirudin	1,696
Pharmacology Intervention/Randomization	1-Year Follow-up	Pharmacology Arm - Unfractionated Heparin	1,702

1 to 10 of 44Source ClinicalTrials.gov

See all 44 participant flow

Adverse events44

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Thrombolysis in Myocardial Infarction Minor Bleeding	Cardiac disorders	Pharmacology Arm - Bivalirudin	57	1,800	64
other	Thrombolysis in Myocardial Infarction Minor Bleeding	Cardiac disorders	Pharmacology Arm - Unfractionated Heparin	89	1,802	91
other	Thrombolysis in Myocardial Infarction Minor Bleeding	Cardiac disorders	Stent Arm - Paclitaxel-Eluting Stent	85	2,257	87
other	Thrombolysis in Myocardial Infarction Minor Bleeding	Cardiac disorders	Stent Arm - Bare Metal Stent	24	749	26
other	Global Use of Strategies to Open Occluded Arteries Mild Bleeding	Cardiac disorders	Pharmacology Arm - Bivalirudin	71	1,800	71
other	Global Use of Strategies to Open Occluded Arteries Mild Bleeding	Cardiac disorders	Pharmacology Arm - Unfractionated Heparin	110	1,802	113
other	Global Use of Strategies to Open Occluded Arteries Mild Bleeding	Cardiac disorders	Stent Arm - Paclitaxel-Eluting Stent	106	2,257	109
other	Global Use of Strategies to Open Occluded Arteries Mild Bleeding	Cardiac disorders	Stent Arm - Bare Metal Stent	28	749	28
serious	Death (cardiac)	Cardiac disorders	Pharmacology Arm - Bivalirudin	50	1,800	50
serious	Death (cardiac)	Cardiac disorders	Pharmacology Arm - Unfractionated Heparin	88	1,802	88

1 to 10 of 44Source ClinicalTrials.gov

See all 44 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pharmacology Arm - Bivalirudin	102	1,800
Total, all-cause mortality	Pharmacology Arm - Unfractionated Heparin	134	1,802
Total, all-cause mortality	Stent Arm - Paclitaxel-Eluting Stent	123	2,257
Total, all-cause mortality	Stent Arm - Bare Metal Stent	48	749
Total, other adverse events	Pharmacology Arm - Bivalirudin	81	1,800
Total, other adverse events	Pharmacology Arm - Unfractionated Heparin	132	1,802
Total, other adverse events	Stent Arm - Paclitaxel-Eluting Stent	122	2,257
Total, other adverse events	Stent Arm - Bare Metal Stent	32	749
Total, serious adverse events	Pharmacology Arm - Bivalirudin	397	1,800
Total, serious adverse events	Pharmacology Arm - Unfractionated Heparin	439	1,802

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers48

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
18499566	DERIVED	PubMed
18585496	DERIVED	PubMed
19420364	DERIVED	PubMed
19717185	DERIVED	PubMed
19796737	DERIVED	PubMed
19858413	DERIVED	PubMed
20723849	DERIVED	PubMed
20805433	DERIVED	PubMed
20888162	DERIVED	PubMed
21220730	DERIVED	PubMed

1 to 10 of 48

See all 48 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons7

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Stent Arm - Paclitaxel-Eluting Stent vs Stent Arm - Bare Metal Stent: Stent Arm - Segment Binary Angiographic Restenosis	Trial comparisons
Stent Arm - Paclitaxel-Eluting Stent vs Stent Arm - Bare Metal Stent: Stent Arm - Ischemic Target Lesion Revascularization	Trial comparisons
Pharmacology Arm - Bivalirudin vs Pharmacology Arm - Unfractionated Heparin: Pharmacology Arm - Non-Coronary Artery Bypass Grafting-Related Major Bleeding	Trial comparisons
Stent Arm - Paclitaxel-Eluting Stent vs Stent Arm - Bare Metal Stent: Stent Arm - Death, Reinfarction, Stroke, or Stent Thrombosis	Trial comparisons
Pharmacology Arm - Bivalirudin vs Pharmacology Arm - Unfractionated Heparin: Pharmacology Arm - Major Adverse Cardiovascular Events	Trial comparisons
Pharmacology Arm - Bivalirudin vs Pharmacology Arm - Unfractionated Heparin: Pharmacology Arm - Major Adverse Cardiovascular Events	Trial comparisons
Pharmacology Arm - Bivalirudin vs Pharmacology Arm - Unfractionated Heparin: Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00433966

GET https://conductscience.org/api/trials/v1/NCT00433966/flow?page=2

API reference For AI assistants