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Comparison of Two Treatment Strategies in Patients With an Acute Coronary Syndrome Without ST Elevation

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00445263
Acronym
SISCA
Enrollment
170
Registered
2007-03-08
Start date
2007-03-31
Completion date
2013-07-31
Last updated
2015-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CORONARY DISEASE

Keywords

CORONARY DISEASE

Brief 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. 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.

Interventions

DRUGTIROFIBAN

intravenous infusion

standard procedure of coronarography

Sponsors

Hospital Avicenne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* High risk ACS without ST elevation

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frame
Mortality, Myocardial Infarction and Revascularization in Emergencyd30

Secondary

MeasureTime frame
Therapeutic Failure (Well Defined) During the First 6 Hours. Clinical Evolution and Electrocardiographyuntil 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 Thrombusd30
Troponin Peak. Left Ventricular Ejection Fraction Before Hospital Exit. Length of Stay in USIC and Hospital. Hemorrhagic Complications.d30

Countries

France

Participant flow

Participants by arm

ArmCount
Early Invasive Strategy
Tirofiban and coronarography within six hours
83
Delayed Invasive Strategy
Coronarography after six hours
86
Total169

Baseline characteristics

CharacteristicEarly Invasive StrategyTotalDelayed Invasive Strategy
Age, Continuous63.9 years65.3 years66.5 years
BMI27.0 kg/m226.6 kg/m226.6 kg/m2
Current smoker
No
39 participants84 participants45 participants
Current smoker
Yes
44 participants85 participants41 participants
Diabetes mellitus
No
48 participants106 participants58 participants
Diabetes mellitus
Yes
35 participants63 participants28 participants
Dyslipidemia
No
38 participants79 participants41 participants
Dyslipidemia
Yes
45 participants90 participants45 participants
Family history of CVS disease
No
63 participants127 participants64 participants
Family history of CVS disease
Yes
20 participants42 participants22 participants
Hypertension
No
33 participants68 participants35 participants
Hypertension
Yes
50 participants101 participants51 participants
On aspirin
No
44 participants98 participants54 participants
On aspirin
Yes
39 participants71 participants32 participants
Previous CABG
No
75 participants157 participants82 participants
Previous CABG
Yes
8 participants12 participants4 participants
Previous MI
No
64 participants130 participants66 participants
Previous MI
Yes
19 participants39 participants20 participants
Previous PCI
No
63 participants131 participants68 participants
Previous PCI
Yes
20 participants38 participants18 participants
Sex: Female, Male
Female
25 Participants48 Participants23 Participants
Sex: Female, Male
Male
58 Participants121 Participants63 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 830 / 86
serious
Total, serious adverse events
2 / 831 / 86

Outcome results

Primary

Mortality, Myocardial Infarction and Revascularization in Emergency

Time frame: d30

ArmMeasureValue (NUMBER)
Early Invasive StrategyMortality, Myocardial Infarction and Revascularization in Emergency2 participants
Delayed Invasive StrategyMortality, Myocardial Infarction and Revascularization in Emergency21 participants
Secondary

Coronarographic Criteria : TIMI Score at the Beginning and the End of the Procedure; Existence of an Intra-coronary Thrombus

Time frame: d30

Secondary

Therapeutic Failure (Well Defined) During the First 6 Hours. Clinical Evolution and Electrocardiography

Time frame: until the exit from the hospital and at d30.

Secondary

Troponin Peak. Left Ventricular Ejection Fraction Before Hospital Exit. Length of Stay in USIC and Hospital. Hemorrhagic Complications.

Time frame: d30

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026