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Angina, UnstablePhase 3NCT00269893

A Study Evaluating the Efficacy and Safety of Abciximab, an Anti-platelet Therapy, in Patients Undergoing High-risk Coronary Angioplasty

A Phase 3 study testing Abciximab in people with Angina, Unstable and Angioplasty, Transluminal, Percutaneous Coronary, run by Centocor, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the effectiveness and safety of abciximab (an anti-platelet therapy) versus placebo in patients undergoing high risk coronary angioplasty. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Abciximab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,038 participants
Where
No sites listed yet
Study dates
Nov 1991to Nov 1992
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients referred for elective or urgent coronary balloon angioplasty or atherectomy with an FDA-approved device in one of the following settings: unstable angina or non-Q wave myocardial infarction, acute Q-wave myocardial infarction, or high-risk clinical/morphological characteristics

Who cannot join

  • Patients with a history of hemorrhagic diathesis - Having had major surgery or clinically significant gastrointestinal or genitourinary bleeding within 6 weeks of study enrollment
  • Having had a stroke within 2 years prior to enrollment or any stroke with significant residual neurological deficit
  • Having occlusion of the left main coronary artery greater than 50% or a history of vasculitis
  • Treated with oral anticoagulants within 7 days (unless prothrombin time is =< 1.2 times control) or intravenous dextran (before or planned for during the treatment angioplasty)

About this study

Official title: A Phase III Double-Blind, Placebo-Controlled Multicenter Study of Abciximab In Patients Undergoing High Risk Coronary Angioplasty (EPIC)

The purpose of this study is to evaluate the effectiveness and safety of abciximab (an anti-platelet therapy) versus placebo in patients undergoing high risk coronary angioplasty.

Read the detailed description

This is a randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of abciximab, an anti-platelet therapy, in patients undergoing high risk coronary angioplasty. The primary outcomes of the study include any of the following: the number of deaths from any cause, or myocardial infarctions and recurrent ischemic events requiring urgent intervention (e.g., repeat angioplasty, coronary artery bypass surgery, intracoronary stent placement, or intra-aortic balloon pump).

Patients receive an abciximab bolus, abciximab bolus plus infusion, or placebo.

Being tested
Abciximab, Placebo
Keywords
Abciximab, Angina, unstable, Angioplasty, transluminal, Percutaneous coronary
Medical subject headings
Angina, Unstable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbciximabDrug

    Also called c7E3 Fab

    0.25 mg/kg of body weight of abciximab either bolus or infusion.

  • PlaceboDrug

    Matching Placebo soulution either bolus or infusion.

Study groups in NCT00269893
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants will receive matching placebo solution bolus followed by matching placebo solution infusion up to 12 hours.
Receives: Drug: Placebo
Abciximab and PlaceboExperimentalParticipants will receive 0.25 milligram per kilogram (mg/kg) of body weight of abciximab (c7E3 Fab) bolus injection followed by followed by placebo solution infusion up to 12 hours.
Receives: Drug: Abciximab; Drug: Placebo
AbciximabExperimentalParticipants will receive 0.25 mg/kg of body weight of abciximab bolus followed by abciximab (c7E3 Fab) infusion up to 12 hours.
Receives: Drug: Abciximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Any of the following within 30 days: Death from any cause; Myocardial infarction; Recurrent ischemic event requiring urgent intervention (repeat angioplasty, coronary artery bypass surgery, intracoronary stent placement, or intra-aortic balloon pump).

    Measured: 30 days after angioplasty

Secondary outcomes (7)

  1. Number of participants With use of thrombolytic agent in catheterization lab

    Measured: Day 1

  2. Time spent in catheterization lab

    Measured: Day 1

  3. Number of balloon Used inflations during angioplasty

    Measured: Day 1

  4. Number of Successful Angioplasty

    Measured: Day 1

  5. Reason for Specific Mortality

    Measured: Up to end of study (30 days after angioplasty)

  6. Number of participants with late major clinical events

    Measured: 30 days after angioplasty up to 6 months after angioplasty

  7. Number of Abrupt Closure

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2005 (estimated)
  2. Study startNov 1991
  3. Primary completionNov 1992
  4. Study completionNov 1992

Resources

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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,038 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00269893
Sponsor's protocol ID
CR006268
Other IDs
C0116T09
Status last verified
Jun 2015
First submitted
22 Dec 2005
Last updated
2 Jun 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • EPIC Investigators. Use of a monoclonal antibody directed against the platelet glycoprotein IIb/IIIa receptor in high-risk coronary angioplasty. N Engl J Med. 1994 Apr 7;330(14):956-61. doi: 10.1056/NEJM199404073301402.

    PubMed 8121459

  • Topol EJ, Ferguson JJ, Weisman HF, Tcheng JE, Ellis SG, Kleiman NS, Ivanhoe RJ, Wang AL, Miller DP, Anderson KM, Califf RM. Long-term protection from myocardial ischemic events in a randomized trial of brief integrin beta3 blockade with percutaneous coronary intervention. EPIC Investigator Group. Evaluation of Platelet IIb/IIIa Inhibition for Prevention of Ischemic Complication. JAMA. 1997 Aug 13;278(6):479-84. doi: 10.1001/jama.278.6.479.

    PubMed 9256222

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abciximab in people with Angina, Unstable and Angioplasty, Transluminal, Percutaneous Coronary, run by Centocor, Inc..

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 4 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 2 Jun 2015. 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. 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?

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.

What does the primary outcome measure?

Any of the following within 30 days: Death from any cause; Myocardial infarction; Recurrent ischemic event requiring urgent intervention (repeat angioplasty, coronary artery bypass surgery, intracoronary stent placement, or intra-aortic balloon pump). (time frame: 30 days after angioplasty). 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 NCT00269893, which also lists 2 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 2 Jun 2015.

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