Coronary DiseasePhase 4NCT00320229
Half-Dose Intracoronary Abciximab Bolus Improves the Mortality Outcome Compared to Standard Intravenous Regimen
A Phase 4 study testing abciximab in people with Coronary Disease and Myocardial Infarction, run by Azienda Sanitaria Ospedaliera at 1 site in Italy.
Trial summary
The aim of our study was to demonstrate that, during a percutaneous coronary intervention, even smaller amounts of abciximab than standard dose, injected locally, could achieve a rapid thrombus resolution and clinical improvement without concomitant differences in hemorrhagic complications Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Coronary Disease, Myocardial Infarction
- What is being tested?
- abciximab
- How many people
- 84 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2004to Jul 2005
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presenting with unstable angina
- presenting with acute myocardial infarction
- eligibility for percutaneous coronary intervention
Who cannot join
- presenting with cardiogenic shock
Trial locations and contacts
1 site in 1 country.
About this study
The aim of our study was to demonstrate that, during a percutaneous coronary intervention, even smaller amounts of abciximab than standard dose, injected locally, could achieve a rapid thrombus resolution and clinical improvement without concomitant differences in hemorrhagic complications
Read the detailed description
Patients both with acute myocardial infarction and unstable angina are prone to extensive intracoronary thrombosis, leading to acute deterioration during percutaneous coronary intervention or thrombosis of the device despite therapy. Intracoronary use of abciximab has reported favourable results. We randomly assigned 84 patients to intracoronary half abciximab bolus (group A) and to standard regimen (group B).
- Conditions
- Coronary Disease, Myocardial Infarction
- Being tested
- abciximab
- Keywords
- angioplasty, stent, abciximab, Platelet Glycoprotein GPIIb-IIIa Complex, myocardial infarction
- Medical subject headings
- Coronary Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abciximabDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startDec 2004
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies 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 4
- Enrolment
- 84 participants
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Ospedaliera
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiologia 2 - Emodinamica - Ospedale Maggiore, Novara, Italy
- Investigators
- Mara Sansa, Principal investigator, Chief Interventional Cardiology - Ospedale Maggiore - Novara - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00320229
- Sponsor's protocol ID
- ABCX-LD
- Status last verified
- Jan 2006
- First submitted
- 18 Apr 2006
- Last updated
- 16 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Half-Dose Intracoronary Abciximab Bolus Improves the Mortality Outcome Compared to Standard Intravenous Regimen
- ClinicalTrials.gov ID
- NCT00320229
- Acronym / sponsor ID
- ABCX-LD
- Conditions
- Coronary Disease, Myocardial Infarction
- Keywords
- angioplasty, stent, abciximab, Platelet Glycoprotein GPIIb-IIIa Complex, myocardial infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 84 participants
- Lead sponsor
- Azienda Sanitaria OspedalieraUniversity, hospital or other
- Collaborators
- Cardiologia 2 - Emodinamica - Ospedale Maggiore, Novara, Italy
- Study start
- Dec 2004
- Study completion
- Jul 2005
- First posted
- 3 May 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 aim of our study was to demonstrate that, during a percutaneous coronary intervention, even smaller amounts of abciximab than standard dose, injected locally, could achieve a rapid thrombus resolution and clinical improvement without concomitant differences in hemorrhagic complications
Detailed description
Patients both with acute myocardial infarction and unstable angina are prone to extensive intracoronary thrombosis, leading to acute deterioration during percutaneous coronary intervention or thrombosis of the device despite therapy. Intracoronary use of abciximab has reported favourable results. We randomly assigned 84 patients to intracoronary half abciximab bolus (group A) and to standard regimen (group B).
Study design
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- presenting with unstable angina
- presenting with acute myocardial infarction
- eligibility for percutaneous coronary intervention
Key exclusion criteria (1 listed)
- presenting with cardiogenic shock
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 |
|---|---|---|
| abciximab | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2006.
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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.
Mara Sansa principal investigator
Chief Interventional Cardiology - Ospedale Maggiore - Novara - Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing abciximab in people with Coronary Disease and Myocardial Infarction, run by Azienda Sanitaria Ospedaliera at 1 site in Italy.
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 1 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: stopped early, as of the sponsor's last update on 16 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early. Results are not available in the source record.
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.
Where can I read the original study information?
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 16 May 2006.