Cardiovascular DiseasePhase 3INSTANTNCT00638976
INSTANT: INtegrilin Plus STenting to Avoid Myocardial Necrosis Trial
A Phase 3 study testing eptifibatide in people with Cardiovascular Disease, run by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS at 1 site in Italy.
Trial summary
Randomized, blind controlled, Multicenter, spontaneous, prospective trial, roughly 20 enrolling centers in Italy, placebo and active drug supply given by GlaxoSmithKline (GSK). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- eptifibatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2007to May 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates for this study must meet all of the following criteria:
- Male or female able to understand and sign a witnessed informed consent
- Age ≥ 18 yo
- Patients with stable (CCS 1-4) or unstable angina pectoris (but with the most recent anginal episode occurring >48 hours before the procedure) or documented silent ischemia
- Stable Hemodynamic conditions (systolic BP > 100 HR > 40 < 100).
- No clinical and ECG changes suggestive of ongoing acute or recent (<48 hours) myocardial infarction.
- Angiographic evidence of a de novo lesion > 50% requiring implantation of two DES in overlapping with a total stent length > 33 mm and reference vessel diameter between 2.5 and 4.0 mm (by visual estimation) in one coronary vessel. Multiple lesions in the same vessels can be included but at least one lesion should require implantation of two DES in overlapping with a total stent length > 33 mm. The definition of multivessel disease requires an intention to treat at least two lesions (with a least one with the characteristics reported above) in two different major epicardial segments. For example, the presence of a lesion in the left anterior descending artery and in the obtuse marginal or the presence of a lesions in the right postero-lateral branch and in a diagonal branch will qualify as multivessel. The presence of lesions in the left anterior descending artery and in the diagonal branch will not qualify as multivessel. Bifurcation lesions and ostial lesions can be included, but only if at least two DES in overlapping with a total stent length > 33 mm are implanted in the same branch. When treating diffuse lesion in the same vessel, overlapping stenting is recommended with high pressure (>14 atm post-dilation) of the overlap zone. There is no maximum stent length to treat one coronary vessel.
Who cannot join
- Female sex with childbearing potential
- Age <18 years
- Ongoing or recent episode (<48 hours) of unstable coronary artery disease (including both ST-elevation and non-ST-elevation acute coronary syndromes)
- Administration of any GP IIb/IIIa inhibitors during the previous 2 weeks
- Serum creatinine >2.5 mg/dl or with a creatinine clearance <40mL/min
- Ongoing serious bleeding or bleeding diathesis
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- Previous stroke in the last 6 months
- Major surgery within the previous 6 weeks
- Platelet count <100,000 per mm3
- Ejection Fraction below 30%
- The patient has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, or sensitivity to contrast which cannot be adequately pre-medicated.
- Hemodynamic instability (systolic blood pressure < 100 mm Hg; heart rate < 40 bpm or >100 bpm; complex ventricular arrhythmias; AV block) requiring balloon counterpulsation or inotropic support.
- The patient is simultaneously participating in another device or drug study. Patient must have completed the follow-up phase of any previous study at least 30 days prior to enrolment in this study.
- Positive clinical history for intracranial neoplasia, AV malformation, aneurysm.
- INR ≥ 2.0 or prothrombin time 1.2 times upper limit of normality
- Clinically manifested reduced liver function
- Programmed surgery within six months
- Angiographic Exclusion Criteria:
- DES implantation in a chronic total occlusion or for the treatment of in-stent restenosis.
- Treatment of lesions where the operator feels necessary the usage of rotactional atherectomy
- Vessel size < 2.25 mm or > 5 mm (by visual estimation).
- Previous implantation of a bare/DES in the target lesion
Trial locations and contacts
1 site in 1 country.
About this study
Randomized, blind controlled, Multicenter, spontaneous, prospective trial, roughly 20 enrolling centers in Italy, placebo and active drug supply given by GlaxoSmithKline (GSK).
Read the detailed description
The Objective of the trial is compare the efficacy and, secondarily, the safety and effectiveness of pre-procedural use of the Gp IIb/IIIa inhibitor eptifibatide in comparison to placebo in patients with diffuse CAD undergoing multiple DES implantation.
- Conditions
- Cardiovascular Disease
- Being tested
- eptifibatide, placebo
- Keywords
- Eptifibatide, IV eptifibatide, GP IIB/IIIA inhibitors, DES stent
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eptifibatideDrug
Enrolled patients will be randomized in the catheterization laboratory, after the decision to perform PCI by means of planned implantation of DES >33 mm in length in the same coronary vessel, to IV placebo or IV eptifibatide (double bolus [180 microg/kg] followed by infusion [2 microg/kg per minute] for 18 to 24 hours after the procedure
placeboDrug
Enrolled patients will be randomized in the catheterization laboratory, after the decision to perform PCI by means of planned implantation of DES >33 mm in length in the same coronary vessel, to IV placebo or IV eptifibatide (double bolus [180 microg/kg] followed by infusion [2 microg/kg per minute] for 18 to 24 hours after the procedure
| Study group | Role | What they receive |
|---|---|---|
| 1.Integrilin, GSK | Other | Pre-procedural use of the Gp IIb/IIIa inhibitor eptifibatide (Integrilin, GSK) vs matched placebo. Receives: Drug: eptifibatide |
| 2 | Placebo comparator | Pre-procedural use of the Gp IIb/IIIa inhibitor eptifibatide (Integrilin, GSK) vs matched placebo. Receives: Drug: placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startNov 2007
- Primary completionFeb 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638976
- Sponsor's protocol ID
- Fondazione Mediolanum 001/2007
- Acronym
- INSTANT
- Status last verified
- May 2010
- First submitted
- 13 Mar 2008
- Last updated
- 28 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INSTANT: INtegrilin Plus STenting to Avoid Myocardial Necrosis Trial
- ClinicalTrials.gov ID
- NCT00638976
- Acronym / sponsor ID
- INSTANT / Fondazione Mediolanum 001/2007
- Conditions
- Cardiovascular Disease
- Keywords
- Eptifibatide, IV eptifibatide, GP IIB/IIIA inhibitors, DES stent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUSUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 19 Mar 2008 (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.
Randomized, blind controlled, Multicenter, spontaneous, prospective trial, roughly 20 enrolling centers in Italy, placebo and active drug supply given by GlaxoSmithKline (GSK).
Detailed description
The Objective of the trial is compare the efficacy and, secondarily, the safety and effectiveness of pre-procedural use of the Gp IIb/IIIa inhibitor eptifibatide in comparison to placebo in patients with diffuse CAD undergoing multiple DES implantation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.Integrilin, GSK | Other | Drug: eptifibatidePre-procedural use of the Gp IIb/IIIa inhibitor eptifibatide (Integrilin, GSK) vs matched placebo. |
| 2 | Placebo comparator | Drug: placeboPre-procedural use of the Gp IIb/IIIa inhibitor eptifibatide (Integrilin, GSK) vs matched placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female able to understand and sign a witnessed informed consent
- Age ≥ 18 yo
- Patients with stable (CCS 1-4) or unstable angina pectoris (but with the most recent anginal episode occurring >48 hours before the procedure) or documented silent ischemia
- Stable Hemodynamic conditions (systolic BP > 100 HR > 40 < 100).
- No clinical and ECG changes suggestive of ongoing acute or recent (<48 hours) myocardial infarction.
Key exclusion criteria (22 listed)
- Female sex with childbearing potential
- Age <18 years
- Ongoing or recent episode (<48 hours) of unstable coronary artery disease (including both ST-elevation and non-ST-elevation acute coronary syndromes)
- Administration of any GP IIb/IIIa inhibitors during the previous 2 weeks
- Serum creatinine >2.5 mg/dl or with a creatinine clearance <40mL/min
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 |
|---|---|---|
| eptifibatideEnrolled patients will be randomized in the catheterization laboratory, after the decision to perform PCI by means of planned implantation of DES >33 mm in length in the same coronary vessel, to IV placebo or IV eptifibatide (double bolus [180 microg/kg] followed by infusion [2 microg/kg per minute] for 18 to 24 hours after the procedure | Drug | 1.Integrilin, GSK |
| placeboEnrolled patients will be randomized in the catheterization laboratory, after the decision to perform PCI by means of planned implantation of DES >33 mm in length in the same coronary vessel, to IV placebo or IV eptifibatide (double bolus [180 microg/kg] followed by infusion [2 microg/kg per minute] for 18 to 24 hours after the procedure | Drug | 2 |
Primary outcome
Not reported in the source record.
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 28 May 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing eptifibatide in people with Cardiovascular Disease, run by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS 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 7 inclusion and 22 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 28 May 2010. 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. 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.
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 28 May 2010.