Trial · NCT00046228
A Study of Abciximab and Reteplase When Administered Prior to Catherization After a Myocardial Infarction (Finesse)
NCT00046228, Phase 3, Completed, Centocor, Inc.; results first posted 2009-05-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Abciximab and Reteplase When Administered Prior to Catherization After a Myocardial Infarction (Finesse). Trials, record NCT00046228. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00046228
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Abciximab and Reteplase When Administered Prior to Catherization After a Myocardial Infarction (Finesse)
- NCT number
- NCT00046228
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,461 participants, actual
- Lead sponsor
- Centocor, Inc.
- Conditions
- Myocardial Infarction
- Interventions
abciximab placebo; reteplase placebo, abciximab, abciximab, Abciximab; reteplase; abciximab placebo; abciximab, abciximab; reteplase placebo; abciximab placebo; abciximab, abciximab placebo; reteplase placebo, abciximab, abciximab, abciximab; reteplase placebo; abciximab placebo; abciximab, Abciximab; reteplase; abciximab placebo; abciximab
- First posted
- 2002-09-25
- Last updated
- 2014-07-31
- Results first posted
- 2009-05-15
- Limitations and caveats
- Some AEs were collected separately per protocol and are reported as Other Pre-Specified Outcomes Measures.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Composite of All-Cause Mortality or Complications of MI at 90 Days. | 90 days | Occurs within 90 days and is composite of all-cause mortality or complications of myocardial infarction (MI) (rehospitalization or emergency department visit for congestive heart failure (CHF), cardiogenic shock, or resuscitated ventricular fibrillation occurring \> 48 hours after randomization). |
| Secondary | Complications of MI as Defined in the Primary Outcome Measure Through 90 Days | 90 Days | The complications of myocardial infarction (MI) is defined as any event of rehospitalization or emergency department visit for CHF, cardiogenic shock, or resuscitated ventricular fibrillation occurring \> 48 hours after randomization. |
| Secondary | All-Cause Mortality Through 90 Days | 90 days | All cause mortality occurred through 90 days from randomization. |
| Secondary | Subjects With ST-Segment Resolution > 70% From Baseline at 60 to 90 Minutes Following Randomization | 60 to 90 minutes | |
| Secondary | All-Cause Mortality Through 1 Year | 1 year | All-cause mortality through 1 year from randomization. |
| Other | Subjects With Intracranial Hemorrhage (Including Hemorrhagic Transformation) Through Discharge/Day 7 | Discharge/Day 7 | All cases of cerebrovascular event were confirmed by a CEC (Clinical Endpoints Committee). |
| Other | Subjects With Non Intracranial Thrombolysis In Myocardial Infarction (TIMI) Bleeding Events Through Discharge/Day 7 | Discharge/Day 7 | Subjects with nonintracranial TIMI bleeding (either major or minor) through discharge/day 7, originating from vascular instrumentation sites, non-instrument related bleeding, as well as overall, were examined. |
| Other | Subjects With Severe Thrombocytopenia Through Discharge/Day 7 | Discharge/Day 7 | Severe thrombocytopenia is defined as platelet count \< 50,000 cells/μL. |
| Other | Subjects With Any Investigator Reported Bleeding Events Through Discharge/Day 7 | Discharge/Day 7 | |
| Other | Subjects With Pre-Specified Complications of Index Myocardial Infarction Through Discharge/Day 7 | Discharge/Day 7 | Number of subjects with one or more of the following: 2nd or 3rd Degree AVB, Asystole, Sustained V Tach, A Fib/Flutter, EMD/Pulseless Electrical Activity, Heart Failure, Tamponade, Myocardial Rupture, Papillary Muscle Rupture, Ventricular Septal Defect, Pulmonary Embolism, Systemic Arterial Embolism and/or Pericarditis/Pericardial Effusion. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Composite of All-Cause Mortality or Complications of MI at 90 Days. | 90 days | Population is the intent-to-treat subjects. The intent-to-treat population is defined as all subjects randomly assigned to a treatment group and classified according to the randomization assignment. | participants | NUMBER |
| SECONDARY | Complications of MI as Defined in the Primary Outcome Measure Through 90 Days | 90 Days | Population is the intent-to-treat subjects. The intent-to-treat population is defined as all subjects that have been randomly assigned to a treatment group and classified according to the randomization assignment. | participants | NUMBER |
| SECONDARY | All-Cause Mortality Through 90 Days | 90 days | Population is the intent-to-treat subjects. The intent-to-treat population is defined as all randomized subjects classified according to the randomization assignment. | participants | NUMBER |
| SECONDARY | Subjects With ST-Segment Resolution > 70% From Baseline at 60 to 90 Minutes Following Randomization | 60 to 90 minutes | Population is the intent-to-treat subjects who were selected for evaluation by electrocardiogram (ECG) core laboratory.Subjects, who were not evaluable for a 60-90 minute ECG, were considered not having a ST segment resolution. | participants | NUMBER |
| SECONDARY | All-Cause Mortality Through 1 Year | 1 year | Population is the intent-to-treat subjects. The intent-to-treat population is defined as all randomized subjects classified according to the randomization assignment. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Subjects With Intracranial Hemorrhage (Including Hemorrhagic Transformation) Through Discharge/Day 7 | Discharge/Day 7 | The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Subjects With Non Intracranial Thrombolysis In Myocardial Infarction (TIMI) Bleeding Events Through Discharge/Day 7 | Discharge/Day 7 | The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received. | participant | NUMBER |
| OTHER_PRE_SPECIFIED | Subjects With Severe Thrombocytopenia Through Discharge/Day 7 | Discharge/Day 7 | The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Subjects With Any Investigator Reported Bleeding Events Through Discharge/Day 7 | Discharge/Day 7 | The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Subjects With Pre-Specified Complications of Index Myocardial Infarction Through Discharge/Day 7 | Discharge/Day 7 | Population is the intent-to-treat subjects. The intent-to-treat population is defined as all randomized subjects classified according to the randomization assignment. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Composite of All-Cause Mortality or Complications of MI at 90 Days. | Primary PCI Group | 86 | participants | ||
| The Composite of All-Cause Mortality or Complications of MI at 90 Days. | Abciximab Facilitated PCI Group | 86 | participants | ||
| The Composite of All-Cause Mortality or Complications of MI at 90 Days. | Reteplase/Abciximab Facilitated PCI Group | 81 | participants | ||
| Complications of MI as Defined in the Primary Outcome Measure Through 90 Days | Primary PCI Group | 72 | participants | ||
| Complications of MI as Defined in the Primary Outcome Measure Through 90 Days | Abciximab Facilitated PCI Group | 61 | participants | ||
| Complications of MI as Defined in the Primary Outcome Measure Through 90 Days | Reteplase/Abciximab Facilitated PCI Group | 61 | participants | ||
| All-Cause Mortality Through 90 Days | Primary PCI Group | 36 | participants | ||
| All-Cause Mortality Through 90 Days | Abciximab Facilitated PCI Group | 45 | participants | ||
| All-Cause Mortality Through 90 Days | Reteplase/Abciximab Facilitated PCI Group | 43 | participants | ||
| Subjects With ST-Segment Resolution > 70% From Baseline at 60 to 90 Minutes Following Randomization | Primary PCI Group | 75 | participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 90 Days | STARTED | Primary PCI Group | 806 | |
| 90 Days | STARTED | Abciximab Facilitated PCI Group | 818 | |
| 90 Days | STARTED | Reteplase/Abciximab Facilitated PCI Group | 828 | |
| 90 Days | COMPLETED | Primary PCI Group | 793 | |
| 90 Days | COMPLETED | Abciximab Facilitated PCI Group | 810 | |
| 90 Days | COMPLETED | Reteplase/Abciximab Facilitated PCI Group | 813 | |
| 90 Days | NOT COMPLETED | Primary PCI Group | 13 | |
| 90 Days | NOT COMPLETED | Abciximab Facilitated PCI Group | 8 | |
| 90 Days | NOT COMPLETED | Reteplase/Abciximab Facilitated PCI Group | 15 | |
| 1 Year | STARTED | Primary PCI Group | 806 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events669
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 |
|---|---|---|---|---|---|---|
| serious | Coronary stenosis | Cardiac disorders | Primary PCI Group | 23 | 795 | |
| serious | Coronary stenosis | Cardiac disorders | Abciximab Facilitated PCI Group | 38 | 805 | |
| serious | Coronary stenosis | Cardiac disorders | Reteplase/Abciximab Facilitated PCI Group | 27 | 814 | |
| serious | Shock cardiogenic | Cardiac disorders | Primary PCI Group | 4 | 795 | |
| serious | Shock cardiogenic | Cardiac disorders | Abciximab Facilitated PCI Group | 9 | 805 | |
| serious | Shock cardiogenic | Cardiac disorders | Reteplase/Abciximab Facilitated PCI Group | 13 | 814 | |
| serious | Unstable angina | Cardiac disorders | Primary PCI Group | 4 | 795 | |
| serious | Unstable angina | Cardiac disorders | Abciximab Facilitated PCI Group | 2 | 805 | |
| serious | Unstable angina | Cardiac disorders | Reteplase/Abciximab Facilitated PCI Group | 6 | 814 | |
| serious | Myocardial infarction | Cardiac disorders | Primary PCI Group | 6 | 795 |
1 to 10 of 669Source ClinicalTrials.gov
See all 669 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Primary PCI Group | ||
| Total, all-cause mortality | Abciximab Facilitated PCI Group | ||
| Total, all-cause mortality | Reteplase/Abciximab Facilitated PCI Group | ||
| Total, other adverse events | Primary PCI Group | 0 | 795 |
| Total, other adverse events | Abciximab Facilitated PCI Group | 0 | 805 |
| Total, other adverse events | Reteplase/Abciximab Facilitated PCI Group | 0 | 814 |
| Total, serious adverse events | Primary PCI Group | 159 | 795 |
| Total, serious adverse events | Abciximab Facilitated PCI Group | 182 | 805 |
| Total, serious adverse events | Reteplase/Abciximab Facilitated PCI Group | 175 | 814 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT00046228
GET https://conductscience.org/api/trials/v1/NCT00046228/results?page=2