Coronary Artery DiseasePhase 4INSTANTNCT01454440
The INtegrilin Plus STenting to Avoid Myocardial Necrosis Trial (INSTANT)
A Phase 4 study testing Eptifibatide in people with Coronary Artery Disease, run by University of Turin, Italy at 1 site in Italy.
Trial summary
Patients with stable coronary artery disease, undergoing PCI by means of implantation of >33 mm of DES, will be randomized single-blinded to eptifibatide plus unfractioned heparin according to the ESPRIT protocol vs placebo plus unfractioned heparin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery 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
- Oct 2007to Oct 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female able to understand and sign a witnessed informed consent,
- age ≥ 18 years
- patients with stable (Canadian Cardiovascular Society I-IV) or unstable angina pectoris (but with the most recent anginal episode occurring >48 hours before the procedure [provided that the most recent CK-MB mass levels are within the limits of normal]) or documented silent ischemia
- stable hemodynamic conditions (systolic blood pressure>100, heart rate>40 and <100)
- no clinical and ECG changes suggestive of ongoing acute or recent (<48 hours) myocardial infarction.
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) without normalization of CK-MB mass levels
- administration of any GP IIb/IIIa inhibitors during the previous 2 weeks,
- serum creatinine >2.5 mg/dl or > 350 micromols/l
- ongoing serious bleeding or bleeding diathesis
Show all 17Show fewer
- previous stroke in the last 6 months
- major surgery within the previous 6 weeks
- platelet count <100,000 per mm3
- ejection Fraction below 30%
- 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; atrioventricular block) requiring balloon counterpulsation or inotropic support
- simultaneous participation in another device or drug study (patient must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this study)
- positive clinical history for intracranial neoplasia, arterio-venous malformation, aneurysm
- INR ≥ 2.0 or prothrombin time 1.2 times upper limit of normality
- clinically manifested reduced liver function
- programmed surgery within one month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A RANDOMIZED TRIAL COMPARING EPTIFIBATIDE AND PLACEBO IN PATIENTS WITH DIFFUSE CORONARY DISEASE UNDERGOING DRUG-ELUTING STENTING
Patients with stable coronary artery disease, undergoing PCI by means of implantation of >33 mm of DES, will be randomized single-blinded to eptifibatide plus unfractioned heparin according to the ESPRIT protocol vs placebo plus unfractioned heparin.
Read the detailed description
BACKGROUND: Despite the availability of several potent antithrombotic agents, the optimal antiplatelet regimen in elective patients undergoing complex percutaneous coronary interventions is still debated. Aim of the INtegrilin plus STenting to Avoid myocardial Necrosis Trial (INSTANT) will be to assess the safety and efficacy of routine usage of the glycoprotein IIb/IIIa inhibitor eptifibatide in subjects already treated with aspirin and clopidogrel, and undergoing implantation of at least 2 drug-eluting stents in the same lesion, thus identifying a clinically stable but anatomically complex patient subset.
DESIGN: This will be a single-blind, placebo-controlled multicenter randomized trial METHODS: Patients with stable coronary artery disease, undergoing percutaneous coronary intervention (PCI) by means of implantation of >33 mm of DES (eg with two 23-mm DES, or one 32-mm and one 12-mm DES), will be randomized, after administration of aspirin and clopidogrel (600 mg loading dose recommended), to eptifibatide and unfractioned heparin according to the ESPRIT protocol vs placebo and unfractioned heparin. Blood draws for CK-MB mass, total CK and cardiac troponin levels will be taken at baseline, 6 and 12 hours post-procedurally. Patients will be followed for clinical events by direct visit or phone contact up to 6 months. The primary end-point of the study will be the rate of abnormal post-PCI CK-MB mass values. Secondary end-points will be: the composite of cardiac death, non-fatal myocardial infarction (MI), urgent target vessel revascularization (TVR), and thrombotic bailout GpIIb/IIIa inhibitor therapy within 180 days, and in-hospital, 1-month and 6-month major adverse cardiovascular events (MACE), defined as the composite of cardiac death, non-fatal MI, or urgent TVR.
IMPLICATIONS: The INSTANT Study will test for the first time the beneficial impact of routine GpIIb/IIIa inhibition on top of double oral antiplatelet treatment in clinically stable yet anatomically complex patients undergoing DES-implantation. Results of this single-blind randomized trial will provide important insights to improve the management strategy of patients and outcomes in the current DES era.
- Conditions
- Coronary Artery Disease
- Being tested
- Eptifibatide
- Keywords
- Coronary artery disease, Eptifibatide, Percutaneous coronary intervention, stable coronary artery disease, percutaneous coronary intervention (PCI), DES
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EptifibatideDrug
Intravenous eptifibatide (double bolus [180 microg/kg] followed by infusion [2 microg/kg per minute] for 18 to 24 hours after the procedure) vs placebo.
| Study group | Role | What they receive |
|---|---|---|
| Eptifibatide | Experimental | Intravenous eptifibatide (double bolus [180 microg/kg] followed by infusion [2 microg/kg per minute] for 18 to 24 hours after the procedure). Receives: Drug: Eptifibatide |
| Placebo | Placebo comparator | Not described Receives: Drug: Eptifibatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal CK-MB level post-PCI
The primary end point will be the rate of elevated post-procedural peak CK-MB mass ratio values (ie above the upper limit of normal [ULN], eg 1.01*ULN, according to each participating hospital laboratory).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startOct 2007
- Primary completionOct 2009
- Study completionOct 2009
Why it stopped: The study was stopped prematurely due to slow enrolment without code breaking.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Biondi Zoccai, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454440
- Sponsor's protocol ID
- 2007-002617-39
- Acronym
- INSTANT
- Status last verified
- Oct 2011
- First submitted
- 6 Oct 2011
- Last updated
- 19 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Biondi-Zoccai G, Valgimigli M, Margheri M, Marzocchi A, Lettieri C, Stabile A, Petronio AS, Binetti G, Bolognese L, Bellone P, Sardella G, Contarini M, Sheiban I, Marra S, Piscione F, Romeo F, Colombo A, Sangiorgi G. Assessing the role of eptifibatide in patients with diffuse coronary disease undergoing drug-eluting stenting: the INtegrilin plus STenting to Avoid myocardial Necrosis Trial. Am Heart J. 2012 May;163(5):835.e1-7. doi: 10.1016/j.ahj.2012.02.009.
PubMed 22607870
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMIZED TRIAL COMPARING EPTIFIBATIDE AND PLACEBO IN PATIENTS WITH DIFFUSE CORONARY DISEASE UNDERGOING DRUG-ELUTING STENTING
- ClinicalTrials.gov ID
- NCT01454440
- Acronym / sponsor ID
- INSTANT / 2007-002617-39
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Eptifibatide, Percutaneous coronary intervention, stable coronary artery disease, percutaneous coronary intervention (PCI), DES
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped prematurely due to slow enrolment without code breaking.
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 19 Oct 2011 (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.
Patients with stable coronary artery disease, undergoing PCI by means of implantation of >33 mm of DES, will be randomized single-blinded to eptifibatide plus unfractioned heparin according to the ESPRIT protocol vs placebo plus unfractioned heparin.
Detailed description
BACKGROUND: Despite the availability of several potent antithrombotic agents, the optimal antiplatelet regimen in elective patients undergoing complex percutaneous coronary interventions is still debated. Aim of the INtegrilin plus STenting to Avoid myocardial Necrosis Trial (INSTANT) will be to assess the safety and efficacy of routine usage of the glycoprotein IIb/IIIa inhibitor eptifibatide in subjects already treated with aspirin and clopidogrel, and undergoing implantation of at least 2 drug-eluting stents in the same lesion, thus identifying a clinically stable but anatomically complex patient subset.
DESIGN: This will be a single-blind, placebo-controlled multicenter randomized trial METHODS: Patients with stable coronary artery disease, undergoing percutaneous coronary intervention (PCI) by means of implantation of >33 mm of DES (eg with two 23-mm DES, or one 32-mm and one 12-mm DES), will be randomized, after administration of aspirin and clopidogrel (600 mg loading dose recommended), to eptifibatide and unfractioned heparin according to the ESPRIT protocol vs placebo and unfractioned heparin. Blood draws for CK-MB mass, total CK and cardiac troponin levels will be taken at baseline, 6 and 12 hours post-procedurally. Patients will be followed for clinical events by direct visit or phone contact up to 6 months. The primary end-point of the study will be the rate of abnormal post-PCI CK-MB mass values. Secondary end-points will be: the composite of cardiac death, non-fatal myocardial infarction (MI), urgent target vessel revascularization (TVR), and thrombotic bailout GpIIb/IIIa inhibitor therapy within 180 days, and in-hospital, 1-month and 6-month major adverse cardiovascular events (MACE), defined as the composite of cardiac death, non-fatal MI, or urgent TVR.
IMPLICATIONS: The INSTANT Study will test for the first time the beneficial impact of routine GpIIb/IIIa inhibition on top of double oral antiplatelet treatment in clinically stable yet anatomically complex patients undergoing DES-implantation. Results of this single-blind randomized trial will provide important insights to improve the management strategy of patients and outcomes in the current DES era.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eptifibatide | Experimental | Drug: EptifibatideIntravenous eptifibatide (double bolus [180 microg/kg] followed by infusion [2 microg/kg per minute] for 18 to 24 hours after the procedure). |
| Placebo | Placebo comparator | Drug: Eptifibatide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male or female able to understand and sign a witnessed informed consent,
- age ≥ 18 years
- patients with stable (Canadian Cardiovascular Society I-IV) or unstable angina pectoris (but with the most recent anginal episode occurring >48 hours before the procedure [provided that the most recent CK-MB mass levels are within the limits of normal]) or documented silent ischemia
- stable hemodynamic conditions (systolic blood pressure>100, heart rate>40 and <100)
- no clinical and ECG changes suggestive of ongoing acute or recent (<48 hours) myocardial infarction.
Key exclusion criteria (17 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) without normalization of CK-MB mass levels
- administration of any GP IIb/IIIa inhibitors during the previous 2 weeks,
- serum creatinine >2.5 mg/dl or > 350 micromols/l
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 |
|---|---|---|
| EptifibatideIntravenous eptifibatide (double bolus [180 microg/kg] followed by infusion [2 microg/kg per minute] for 18 to 24 hours after the procedure) vs placebo. | Drug | Eptifibatide, Placebo |
Primary outcome
Abnormal CK-MB level post-PCI
Time frame: 2 weeks
The primary end point will be the rate of elevated post-procedural peak CK-MB mass ratio values (ie above the upper limit of normal [ULN], eg 1.01*ULN, according to each participating hospital laboratory).
Results and safety
The study was stopped early (reason given: The study was stopped prematurely due to slow enrolment without code breaking.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2011.
- Derived from this study: PubMed 22607870Biondi-Zoccai G, Valgimigli M, Margheri M, Marzocchi A, Lettieri C, Stabile A, Petronio AS, Binetti G, Bolognese L, Bellone P, Sardella G, Contarini M, Sheiban I, Marra S, Piscione F, Romeo F, Colombo A, Sangiorgi G. Assessing the role of eptifibatide in patients with diffuse coronary disease undergoing drug-eluting stenting: the INtegrilin plus STenting to Avoid myocardial Necrosis Trial. Am Heart J. 2012 May;163(5):835.e1-7. doi: 10.1016/j.ahj.2012.02.009.
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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 4 study testing Eptifibatide in people with Coronary Artery Disease, run by University of Turin, Italy 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 5 inclusion and 17 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 19 Oct 2011. 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 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 (reason given: The study was stopped prematurely due to slow enrolment without code breaking.). 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.
What does the primary outcome measure?
Abnormal CK-MB level post-PCI (time frame: 2 weeks). 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 NCT01454440, which also lists 1 linked publication.
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 19 Oct 2011.