E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of unstable angina/non-ST elevation myocardial infarction (UA/NSTEMI) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064347 |
E.1.2 | Term | Non ST segment elevation myocardial infarction |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the safety of two dose regimens of adjunctive i.v. UFH (low or standard dose) during PCI in high risk patients with UA/NSTEMI initially treated with s.c. fondaparinux and referred for early coronary angiography.
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E.2.2 | Secondary objectives of the trial |
To evaluate the net clinical benefit of two dose regimens of adjunctive i.v. UFH (low or standard dose) during PCI in high risk patients with UA/NSTEMI initially treated with s.c. fondaparinux and referred for early coronary angiography.
To evaluate the relative efficacy outcomes of two dose regimens of adjunctive i.v. UFH (low or standard dose) during PCI in high risk patients with UA/NSTEMI patients initially treated with s.c. fondaparinux and referred for early coronary angiography.
To evaluate if the bleeding and PCI-related complications associated with adjunctive UFH during PCI in UA/NSTEMI patients initially treated with s.c. fondaparinux is comparable to that observed in OASIS 5 when fondaparinux was used as the sole anticoagulant during PCI.
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
NSTEACS (A Randomized Comparison of a Strategy of Culprit-Only versus Complete Revascularization with Percutaneous Coronary Intervention in Patients with Non ST elevation Acute Coronary Syndromes [NSTEACS])
Objectives:
To determine whether a strategy of complete revascularization with PCI is superior to a strategy of culprit vessel-only PCI in reducing the rate of death, new MI, or refractory ischemia at 1 year.
BLOOD STUDY
Objectives:
To examine the association between anticoagulation intensity during fondaparinux therapy and risk of MI, stroke or death.
To examine the association between anticoagulation intensity during fondaparinux therapy and risk of bleeding.
To examine the association between inhibition of contact activation and risk of catheter thrombosis.
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E.3 | Principal inclusion criteria |
Subjects eligible for enrolment in the cohort study must meet all of the following criteria:
Presenting or admitted to hospital with symptoms suspected to represent UA or NSTEMI, i.e., clinical history consistent with new onset, or a worsening pattern of, characteristic ischemic chest pain or ischemic symptoms occurring at rest or with minimal activity (lasting longer than 5 minutes or requiring sublingual nitroglycerine for relief of the pain).
Available to be enrolled within 48 hours of the onset of the most recent episode of symptoms.
Planned coronary angiography, with PCI if indicated, within 72 hours of enrolment where possible.
At least two of the three following additional criteria: • Age ≥ 60 years • Troponin T or I or CK-MB above the upper limit of normal for the local institution; • ECG changes compatible with ischemia, i.e., ST depression at least 1 mm in 2 contiguous leads or T wave inversion > 3 mm or any dynamic ST shift or transient ST elevation.
Written informed consent dated and signed
In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category |
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E.4 | Principal exclusion criteria |
Subjects meeting any of the following criteria must not be enrolled in the study:
Age < 21 years.
Any contraindication to UFH or fondaparinux
Contraindication for angiography or PCI at baseline
Subjects requiring urgent (<120 minutes) coronary angiography as characterized by those with: • refractory or recurrent angina associated with dynamic ST-deviation • heart failure • life-threatening arrhythmias • haemodynamic instability
Subjects already receiving treatment with enoxaparin (or other LMWH), bivalirudin or UFH for treatment of the qualifying events unless the last administered (i.v. or s.c.) dose was: • ≥ 8 hours for LMWH • ≥60 minutes for bivalirudin • ≥90 minutes for UFH
Hemorrhagic stroke within the last 12 months.
Indication for anti-coagulation other than ACS during the index hospitalization.
Pregnancy or women of childbearing potential who are not using an effective method of contraception.
Co-morbid condition with life expectancy less than 6 months.
Currently receiving an experimental pharmacological agent.
Revascularization procedure already performed for the qualifying event.
Severe renal insufficiency (i.e., estimated creatinine clearance <20 ml/min)
The French subject has participated in any study using an investigational drug during the previous 56 days |
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E.5 End points |
E.5.1 | Primary end point(s) |
The designated primary outcome is:
• Composite of peri-PCI* major bleeding, minor bleeding or major vascular access site complications
* Peri-PCI is defined from randomisation up to 48 hours post PCI procedure. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 129 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial will end when the last subject enrolled in the trial has completed their final visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |