CORONARY DISEASEPhase 4SISCANCT00445263
Comparison of Two Treatment Strategies in Patients With an Acute Coronary Syndrome Without ST Elevation
A Phase 4 study testing TIROFIBAN and CORONAROGRAPHY in people with CORONARY DISEASE, run by Hospital Avicenne at 1 site in France.
Trial summary
The acute coronary syndrome (ACS) without ST elevation is a frequent pathology. The main evolutionary risk of these patients is the coronary thrombosis and its self complications. The platelets aggregation plays a major role in the physiopathology of the ACS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CORONARY DISEASE
- What is being tested?
- TIROFIBAN and CORONAROGRAPHY
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2007to Jul 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- High risk ACS without ST elevation
Who cannot join
- Age <18 years
- Pregnancy
- Persistence of the ST elevation
- Recent left branch block
- Cardiac failure or cardiogenic shock (Kilip 3 or 4)
- Treatment by anti-vitamin K
- Contra-indication to the use of one of the following treatments: aspirin, clopidogrel, enoxaparine, anti GP IIb/IIIa (tirofiban)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment by Anti GP IIb/IIIa in the Setting of a Strategy of Early Coronarography to Patients With an Acute Coronary Syndrome Without ST Elevation
The acute coronary syndrome (ACS) without ST elevation is a frequent pathology. The main evolutionary risk of these patients is the coronary thrombosis and its self complications. The platelets aggregation plays a major role in the physiopathology of the ACS. The therapeutic arsenal of the anti-thrombosis essentially resting on aspirin and heparin has been reinforced lately by the inhibitors of the glycoprotein anti GP IIb/IIIa. The profit of these products in the ACS with or without ST elevation, associated or not to coronarography, has clearly been demonstrated. This profit is more marked when patients are at high risk of complications. Thus, the use of an anti GP IIb/IIIa is recommended among patients at "high risk" for whom a coronarography is planned, in the last international recommendations of the European Cardiology Society (ESC), the American Heart Association and the American College of Chest Physician. Otherwise, some authors have proposed An early invasive strategy based on coronarography with discordant results. The ideal delay of realization of this coronarography is unknown. It varies according to the studies between 2.5 hours to 48 hours. Once again, patients at high risk seem to benefit the more of such a strategy if it is set precociously.
Objective To compare an invasive strategy associating an early administration of tirofiban and a coronarography achieved in the 6 hours after the randomization to a conservative strategy in a population of high risk patients with ACS without ST elevation.
Design Multicentric, prospective, randomized study.
Read the detailed description
Patient's selection Patient of more than 18 years with a ACS defined by a thoracic pain of more than 20 minutes that occurred during the last 24 hours, anomalies on EKG and one of the following criteria : diabetes; recurrence of coronary pain; precocious pain post-myocardial infarction; falling of the ST segment of > 1 mm; transient elevation of the ST segment > 1 mm; elevation of the I troponin, T troponin or CPK MB; hemodynamic instability; ventricular arrhythmia; TIMI score > 5
Therapeutic modes All patients receive : aspirin, clopidogrel, enoxaparine. Trinitrin and analgesics are at the clinician's appreciation. Besides, either they receive an anti GP IIb/IIIa: tirofiban (Agrastat®) and are oriented in cardiology to have a coronarography in the six hours or they are oriented in cardiology to receive the classical treatment, guided by the investigations searching for signs of myocardial ischemia.
- Conditions
- CORONARY DISEASE
- Being tested
- TIROFIBAN, CORONAROGRAPHY
- Keywords
- CORONARY DISEASE
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIROFIBANDrug
Also called IIb/IIIa GP inhibitor
intravenous infusion
CORONAROGRAPHYProcedure or surgery
Also called angiography
standard procedure of coronarography
| Study group | Role | What they receive |
|---|---|---|
| Early Invasive strategy | Experimental | Tirofiban and coronarography within 6 hours Receives: Drug: TIROFIBAN; Procedure: CORONAROGRAPHY |
| Delayed invasive strategy | Active comparator | Coronarography after 6 hours Receives: Procedure: CORONAROGRAPHY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality, Myocardial Infarction and Revascularization in Emergency
Measured: d30
Secondary outcomes (3)
Therapeutic Failure (Well Defined) During the First 6 Hours. Clinical Evolution and Electrocardiography
Measured: until the exit from the hospital and at d30.
Coronarographic Criteria : TIMI Score at the Beginning and the End of the Procedure; Existence of an Intra-coronary Thrombus
Measured: d30
Troponin Peak. Left Ventricular Ejection Fraction Before Hospital Exit. Length of Stay in USIC and Hospital. Hemorrhagic Complications.
Measured: d30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2010
- Study completionJul 2013
Why it stopped: Because of inclusion delay
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Avicenne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FREDERIC LAPOSTOLLE, Hospital Avicenne
- Investigators
- FREDERIC LAPOSTOLLE, MD, Principal investigator, SAMU 93 - AVICENNE HOSPITALFREDERIC ADNET, PHD, Study director, SAMU 93 - AVICENNE HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00445263
- Sponsor's protocol ID
- PC/AP 39-2005
- Acronym
- SISCA
- Status last verified
- Feb 2015
- First submitted
- 7 Mar 2007
- Last updated
- 27 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment by Anti GP IIb/IIIa in the Setting of a Strategy of Early Coronarography to Patients With an Acute Coronary Syndrome Without ST Elevation
- ClinicalTrials.gov ID
- NCT00445263
- Acronym / sponsor ID
- SISCA / PC/AP 39-2005
- Conditions
- CORONARY DISEASE
- Keywords
- CORONARY DISEASE
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because of inclusion delay
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Hospital AvicenneUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 8 Mar 2007 (estimated)
- Results
- Posted 9 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The acute coronary syndrome (ACS) without ST elevation is a frequent pathology. The main evolutionary risk of these patients is the coronary thrombosis and its self complications. The platelets aggregation plays a major role in the physiopathology of the ACS. The therapeutic arsenal of the anti-thrombosis essentially resting on aspirin and heparin has been reinforced lately by the inhibitors of the glycoprotein anti GP IIb/IIIa. The profit of these products in the ACS with or without ST elevation, associated or not to coronarography, has clearly been demonstrated. This profit is more marked when patients are at high risk of complications. Thus, the use of an anti GP IIb/IIIa is recommended among patients at "high risk" for whom a coronarography is planned, in the last international recommendations of the European Cardiology Society (ESC), the American Heart Association and the American College of Chest Physician. Otherwise, some authors have proposed An early invasive strategy based on coronarography with discordant results. The ideal delay of realization of this coronarography is unknown. It varies according to the studies between 2.5 hours to 48 hours. Once again, patients at high risk seem to benefit the more of such a strategy if it is set precociously.
Objective To compare an invasive strategy associating an early administration of tirofiban and a coronarography achieved in the 6 hours after the randomization to a conservative strategy in a population of high risk patients with ACS without ST elevation.
Design Multicentric, prospective, randomized study.
Detailed description
Patient's selection Patient of more than 18 years with a ACS defined by a thoracic pain of more than 20 minutes that occurred during the last 24 hours, anomalies on EKG and one of the following criteria : diabetes; recurrence of coronary pain; precocious pain post-myocardial infarction; falling of the ST segment of > 1 mm; transient elevation of the ST segment > 1 mm; elevation of the I troponin, T troponin or CPK MB; hemodynamic instability; ventricular arrhythmia; TIMI score > 5
Therapeutic modes All patients receive : aspirin, clopidogrel, enoxaparine. Trinitrin and analgesics are at the clinician's appreciation. Besides, either they receive an anti GP IIb/IIIa: tirofiban (Agrastat®) and are oriented in cardiology to have a coronarography in the six hours or they are oriented in cardiology to receive the classical treatment, guided by the investigations searching for signs of myocardial ischemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Invasive strategy | Experimental | Drug: TIROFIBAN, Procedure: CORONAROGRAPHYTirofiban and coronarography within 6 hours |
| Delayed invasive strategy | Active comparator | Procedure: CORONAROGRAPHYCoronarography after 6 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- High risk ACS without ST elevation
Key exclusion criteria (7 listed)
- Age <18 years
- Pregnancy
- Persistence of the ST elevation
- Recent left branch block
- Cardiac failure or cardiogenic shock (Kilip 3 or 4)
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 |
|---|---|---|
| TIROFIBANAlso: IIb/IIIa GP inhibitorintravenous infusion | Drug | Early Invasive strategy |
| CORONAROGRAPHYAlso: angiographystandard procedure of coronarography | Procedure or surgery | Delayed invasive strategy, Early Invasive strategy |
Primary outcome
Mortality, Myocardial Infarction and Revascularization in Emergency
Time frame: d30
3 secondary outcomes
Therapeutic Failure (Well Defined) During the First 6 Hours. Clinical Evolution and Electrocardiography
Time frame: until the exit from the hospital and at d30.
Coronarographic Criteria : TIMI Score at the Beginning and the End of the Procedure; Existence of an Intra-coronary Thrombus
Time frame: d30
Troponin Peak. Left Ventricular Ejection Fraction Before Hospital Exit. Length of Stay in USIC and Hospital. Hemorrhagic Complications.
Time frame: d30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
FREDERIC LAPOSTOLLE, MD principal investigator
SAMU 93 - AVICENNE HOSPITAL
FREDERIC ADNET, PHD study director
SAMU 93 - AVICENNE HOSPITAL
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 TIROFIBAN and CORONAROGRAPHY in people with CORONARY DISEASE, run by Hospital Avicenne at 1 site in France.
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 7 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 27 Feb 2015. 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 France. 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?
Yes. Results are posted in the registry (first posted 9 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mortality, Myocardial Infarction and Revascularization in Emergency (time frame: d30). It is what the study was designed to measure, not a finding.
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 27 Feb 2015.