Angioplasty, Transluminal, Percutaneous CoronaryPhase 3NCT00271401
A Study Comparing the Efficacy and Safety of Intracoronary Stenting With or Without Abciximab, an Anti-Platelet Therapy, and Conventional Coronary Angioplasty With Abciximab
A Phase 3 study testing Angioplasty, Intracoronary Stent and Abxicimab in people with Angioplasty, Transluminal, Percutaneous Coronary, run by Centocor, Inc..
Trial summary
The purpose of this study is to compare the effectiveness and safety of intracoronary stenting with or without abciximab, an anti-platelet therapy, and conventional coronary angioplasty with abciximab in patients undergoing percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Angioplasty, Transluminal, Percutaneous Coronary
- What is being tested?
- Angioplasty, Intracoronary Stent and Abxicimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,399 participants
- Where
- No sites listed yet
- Study dates
- Jul 1996to Sep 1997
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred for elective or urgent percutaneous coronary intervention
- Who are suitable candidates for either conventional angioplasty or primary intracoronary stent implantation
- Having a target artery (native or graft) stenosis of >= 60% (visual estimation)
Who cannot join
- Patients with acute ST-segment elevation myocardial infarction within the previous 12 hours
- With a planned staged procedure or having an unprotected left main coronary artery stenosis > 50%
- With active internal bleeding, having a condition that may increase the risk of bleeding, or receiving ongoing treatment with an oral anticoagulant at the time of study entry
- Having had a percutaneous coronary intervention within the previous 3 months or prior intracoronary stent placement in a target vessel
- Having hypertension with systolic blood pressure > 180 mm Hg or diastolic blood pressure > 100 mm Hg at the time of study entry, or a platelet count < 100,000/μL at baseline
About this study
Official title: A Multicenter, Randomized Trial Evaluating 30-day and 6-month Clinical Outcomes With Three Different Treatment Strategies (Coronary Angioplasty + Abciximab, Intracoronary Stent + Abciximab, and Intracoronary Stent + Placebo) in Patients Undergoing Percutaneous Coronary Intervention
The purpose of this study is to compare the effectiveness and safety of intracoronary stenting with or without abciximab, an anti-platelet therapy, and conventional coronary angioplasty with abciximab in patients undergoing percutaneous coronary intervention.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and effectiveness of intracoronary stenting with or without abciximab, an anti-platelet therapy, and conventional coronary angioplasty with abciximab in patients undergoing percutaneous coronary intervention. Patients will be randomly assigned to one of three treatment groups: coronary angioplasty plus abciximab, intracoronary stent plus abciximab, or intracoronary stent plus placebo. The primary measures of effectiveness will be a 30-day composite, clinical outcome as determined by the number of deaths, myocardial infarctions, or urgent repeat revascularizations. Please see attached results.
Patients will receive one of three different treatments: Coronary angioplasty plus abciximab; Intracoronary stent plus abciximab; or Intracoronary stent plus placebo.
- Being tested
- Angioplasty, Intracoronary Stent, Abxicimab, Heparin, Placebo
- Keywords
- Stents, Angioplasty, Transluminal, Percutaneous Coronary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngioplastyOther
Intracoronary StentOther
AbxicimabDrug
HeparinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Angioplasty With Abciximab Plus Low-Dose Heparin | Experimental | Participants will receive conventional angioplasty/atherectomy along with bolus abciximab 0.25 milligram per kilogram (mg/kg) of body weight followed by a 0.125 microgram per kilogram per minute (mcg/kg/minute) infusion for 12 hours plus 7 unit per kilogram per hour (U/kg/hr) continuous infusion of heparin. Receives: Other: Angioplasty; Drug: Abxicimab; Drug: Heparin |
| Intracoronary Stent With Reo Pro Plus Low Dose Heparin | Experimental | Participants will receive intracoronary stent along with receive bolus abciximab 0.25 mg/kg of body weight followed by a 0.125 mcg/kg/minute infusion for 12 hours plus 7 U/kg/hr continuous infusion of heparin (low dose). Receives: Other: Intracoronary Stent; Drug: Abxicimab; Drug: Heparin |
| Intracoronary Stent With Placebo Plus Standard Dose Heparin | Placebo comparator | Participants will receive intracoronary stent along with bolus placebo followed by placebo infusion for 12 hours plus 10 U/kg/hr continuous infusion of heparin (standard dose). Receives: Other: Intracoronary Stent; Drug: Heparin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With any one of these: Deaths, Myocardial Infarctions, or Urgent Repeat Revascularizations
Measured: Up to 30 days
Secondary outcomes (1)
Number of Particpants with Angiographic Outcome, Death or Myocardial Infraction and Cardiovascular Functional Status
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2006 (estimated)
- Study startJul 1996
- Primary completionSep 1997
- Study completionSep 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Angioplasty, Transluminal, Percutaneous CoronaryStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centocor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Centocor, Inc. Clinical Trial, Study director, Centocor, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271401
- Sponsor's protocol ID
- CR006265
- Status last verified
- May 2015
- First submitted
- 30 Dec 2005
- Last updated
- 25 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Topol EJ, Mark DB, Lincoff AM, Cohen E, Burton J, Kleiman N, Talley D, Sapp S, Booth J, Cabot CF, Anderson KM, Califf RM. Outcomes at 1 year and economic implications of platelet glycoprotein IIb/IIIa blockade in patients undergoing coronary stenting: results from a multicentre randomised trial. EPISTENT Investigators. Evaluation of Platelet IIb/IIIa Inhibitor for Stenting. Lancet. 1999 Dec 11;354(9195):2019-24. doi: 10.1016/s0140-6736(99)10018-7.
PubMed 10636365EPISTENT Investigators. Randomised placebo-controlled and balloon-angioplasty-controlled trial to assess safety of coronary stenting with use of platelet glycoprotein-IIb/IIIa blockade. Lancet. 1998 Jul 11;352(9122):87-92. doi: 10.1016/s0140-6736(98)06113-3.
PubMed 9672272
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Trial Evaluating 30-day and 6-month Clinical Outcomes With Three Different Treatment Strategies (Coronary Angioplasty + Abciximab, Intracoronary Stent + Abciximab, and Intracoronary Stent + Placebo) in Patients Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT00271401
- Acronym / sponsor ID
- CR006265
- Keywords
- Stents, Angioplasty, Transluminal, Percutaneous Coronary
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,399 participants (actual)
- Lead sponsor
- Centocor, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 1996
- Primary completion
- Sep 1997 (actual)
- Study completion
- Sep 1997 (actual)
- First posted
- 2 Jan 2006 (estimated)
- Results
- Not posted in the source record
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 compare the effectiveness and safety of intracoronary stenting with or without abciximab, an anti-platelet therapy, and conventional coronary angioplasty with abciximab in patients undergoing percutaneous coronary intervention.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and effectiveness of intracoronary stenting with or without abciximab, an anti-platelet therapy, and conventional coronary angioplasty with abciximab in patients undergoing percutaneous coronary intervention. Patients will be randomly assigned to one of three treatment groups: coronary angioplasty plus abciximab, intracoronary stent plus abciximab, or intracoronary stent plus placebo. The primary measures of effectiveness will be a 30-day composite, clinical outcome as determined by the number of deaths, myocardial infarctions, or urgent repeat revascularizations. Please see attached results.
Patients will receive one of three different treatments: Coronary angioplasty plus abciximab; Intracoronary stent plus abciximab; or Intracoronary stent plus placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Angioplasty With Abciximab Plus Low-Dose Heparin | Experimental | Other: Angioplasty, Drug: Abxicimab, Drug: HeparinParticipants will receive conventional angioplasty/atherectomy along with bolus abciximab 0.25 milligram per kilogram (mg/kg) of body weight followed by a 0.125 microgram per kilogram per minute (mcg/kg/minute) infusion for 12 hours plus 7 unit per kilogram per hour (U/kg/hr) continuous infusion of heparin. |
| Intracoronary Stent With Reo Pro Plus Low Dose Heparin | Experimental | Other: Intracoronary Stent, Drug: Abxicimab, Drug: HeparinParticipants will receive intracoronary stent along with receive bolus abciximab 0.25 mg/kg of body weight followed by a 0.125 mcg/kg/minute infusion for 12 hours plus 7 U/kg/hr continuous infusion of heparin (low dose). |
| Intracoronary Stent With Placebo Plus Standard Dose Heparin | Placebo comparator | Other: Intracoronary Stent, Drug: Heparin, Drug: PlaceboParticipants will receive intracoronary stent along with bolus placebo followed by placebo infusion for 12 hours plus 10 U/kg/hr continuous infusion of heparin (standard dose). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients referred for elective or urgent percutaneous coronary intervention
- Who are suitable candidates for either conventional angioplasty or primary intracoronary stent implantation
- Having a target artery (native or graft) stenosis of >= 60% (visual estimation)
Key exclusion criteria (5 listed)
- Patients with acute ST-segment elevation myocardial infarction within the previous 12 hours
- With a planned staged procedure or having an unprotected left main coronary artery stenosis > 50%
- With active internal bleeding, having a condition that may increase the risk of bleeding, or receiving ongoing treatment with an oral anticoagulant at the time of study entry
- Having had a percutaneous coronary intervention within the previous 3 months or prior intracoronary stent placement in a target vessel
- Having hypertension with systolic blood pressure > 180 mm Hg or diastolic blood pressure > 100 mm Hg at the time of study entry, or a platelet count < 100,000/μL at baseline
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 |
|---|---|---|
| Angioplasty | Other | Angioplasty With Abciximab Plus Low-Dose Heparin |
| Intracoronary Stent | Other | Intracoronary Stent With Placebo Plus Standard Dose Heparin, Intracoronary Stent With Reo Pro Plus Low Dose Heparin |
| Abxicimab | Drug | Angioplasty With Abciximab Plus Low-Dose Heparin, Intracoronary Stent With Reo Pro Plus Low Dose Heparin |
| Heparin | Drug | Angioplasty With Abciximab Plus Low-Dose Heparin, Intracoronary Stent With Placebo Plus Standard Dose Heparin, Intracoronary Stent With Reo Pro Plus Low Dose Heparin |
| Placebo | Drug | Intracoronary Stent With Placebo Plus Standard Dose Heparin |
Primary outcome
Number of Participants With any one of these: Deaths, Myocardial Infarctions, or Urgent Repeat Revascularizations
Time frame: Up to 30 days
1 secondary outcome
Number of Particpants with Angiographic Outcome, Death or Myocardial Infraction and Cardiovascular Functional Status
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2015.
- Results publication: PubMed 10636365Topol EJ, Mark DB, Lincoff AM, Cohen E, Burton J, Kleiman N, Talley D, Sapp S, Booth J, Cabot CF, Anderson KM, Califf RM. Outcomes at 1 year and economic implications of platelet glycoprotein IIb/IIIa blockade in patients undergoing coronary stenting: results from a multicentre randomised trial. EPISTENT Investigators. Evaluation of Platelet IIb/IIIa Inhibitor for Stenting. Lancet. 1999 Dec 11;354(9195):2019-24. doi: 10.1016/s0140-6736(99)10018-7.
- Results publication: PubMed 9672272EPISTENT Investigators. Randomised placebo-controlled and balloon-angioplasty-controlled trial to assess safety of coronary stenting with use of platelet glycoprotein-IIb/IIIa blockade. Lancet. 1998 Jul 11;352(9122):87-92. doi: 10.1016/s0140-6736(98)06113-3.
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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.
Centocor, Inc. Clinical Trial study director
Centocor, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Angioplasty, Intracoronary Stent and Abxicimab in people with 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 3 inclusion and 5 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 25 May 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?
Number of Participants With any one of these: Deaths, Myocardial Infarctions, or Urgent Repeat Revascularizations (time frame: Up to 30 days). 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 NCT00271401, 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 25 May 2015.