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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 April 2022 |
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Main ID: |
EUCTR2004-001682-17-ES |
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Date of registration:
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02/06/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Randomized Dose Ranging Study of Hexadecasaccharide including Active Control, in Patients with Unstable Angina or Non-ST-segment Elevation Myocardial Infarction Scheduled to Undergo Percutaneous Coronary Intervention
Estudio aleatorizado de búsqueda de dosis de hexadesacárido incluyendo control activo de pacientes con angina inestable o infarto de miocardio sin elevación del segmento ST programados para someterse a intervención coronaria percutánea(SHINE) - SHINE
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Scientific title:
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A Randomized Dose Ranging Study of Hexadecasaccharide including Active Control, in Patients with Unstable Angina or Non-ST-segment Elevation Myocardial Infarction Scheduled to Undergo Percutaneous Coronary Intervention
Estudio aleatorizado de búsqueda de dosis de hexadesacárido incluyendo control activo de pacientes con angina inestable o infarto de miocardio sin elevación del segmento ST programados para someterse a intervención coronaria percutánea(SHINE) - SHINE |
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Date of first enrolment:
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14/01/2005 |
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Target sample size:
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1800 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001682-17 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: double blind for the 5 hexadecasaccharide doses
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Spain
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Men and women older than 21 years
Patients with a diagnosis of unstable angina or NSTEMI presenting with an episode of angina (with an accelerating pattern or prolonged [>20 minutes] or recurrent episodes at rest or with minimal effort) within the preceding 24 hours and for whom coronary angiography is planned and PCI is anticipated to occur in the index hospitalization and within 48 hours
New ST-segment depression of = 0.1 mV or transient (less than 20 minutes) ST-segment elevation of = 0.1 mV in at least two leads on the electrocardiogram and/or elevated levels of Troponin T > 0.1 ng/ml or Troponin I > 0.2 ng/ml
Patients in whom the upfront use of GPIIb/IIIa inhibitors (tirofiban or eptifibatide) before angiography is deemed not necessary
Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Known allergy or any contra-indication to abciximab (ReoPro®) or heparin.
Administration of LMWH within 8 hours, bivalirudin, eptifibatide, tirofiban within 12 hours and abciximab (ReoPro®) within 48 hours preceding randomization.
Administration of UFH within 2 hours before randomization (unless activated partial thromboplastin time [aPTT] was £50 seconds or activated clotting time [ACT] was £175 seconds at the time of randomization).
Requirement for warfarin therapy.
Active bleeding or increased risk of bleeding or any history of intracranial hemorrhage.
History of ischemic stroke within the preceding 6 months.
Poorly controlled hypertension despite antihypertensive therapy (blood pressure >180/110 mm Hg).
History of clinically significant thrombocytopenia or neutropenia.
Serum creatinine >2.5 mg/dl [221 µmol/L] and /or dependency on renal dialysis.
Recent CABG within the previous month or known left main trunk stenosis of more than 50% severity.
Pregnant or nursing women, or women of childbearing potential who are not using an effective contraceptive method.
Administration of any investigational treatment (drug or device) in the preceding 30 days.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Coronary desease
MedDRA version: 7.0
Level: LLT
Classification code 10046251
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Intervention(s)
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Product Name: Hexadecasaccharide
Product Code: SR123781A/Sanorg123781A
Pharmaceutical Form: Solution for injection
Current Sponsor code: SR123781A/Sanorg123781A
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.25-
Product Name: Hexadecasaccharide
Product Code: SR123781A/Sanorg123781A
Pharmaceutical Form: Solution for injection
Current Sponsor code: SR123781A/Sanorg123781A
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.50-
Product Name: Hexadecasaccharide
Product Code: SR123781A/Sanorg123781A
Pharmaceutical Form: Solution for injection
Current Sponsor code: SR123781A/Sanorg123781A
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1.0-
Product Name: Hexadecasaccharide
Product Code: SR123781A/Sanorg123781A
Pharmaceutical Form: Solution for injection
Current Sponsor code: SR123781A/Sanorg123781A
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2.0-
Product Name: Hexadecasaccharide
Product Code: SR123781A/Sanorg123781A
Pharmaceutical Form: Solution for injection
Current Sponsor code: SR123781A/Sanorg123781A
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 4.0-
Trade Name: Reopro
Product Name: Reopro
Pharmaceutical Form: Solution for injection
INN or Proposed INN: abciximab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2-
Trade Name: unfractioned heparin purchased on Spain market (trade name at discretion of investigator)
Product Name: UFH (unfractioned heparin)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: heparin sodium
Other descriptive name: UFH
Con
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Primary Outcome(s)
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Main Objective: To evaluate the dose effect of hexadecasaccharide (5 once daily regimens) in patients with unstable angina or non-ST-segment elevation myocardial infarction who are scheduled to undergo percutaneous coronary intervention within 48 hours
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Primary end point(s): The primary end point of the trial is a composite of all cause death, new myocardial infarction, or severe myocardial ischemia requiring urgent repeat target vessel revascularization within 7 days following randomization
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Secondary Objective: To compare the efficacy and safety between each dose of hexadecasaccharide with the active control of UFH and abciximab (ReoPro®)·
To assess the effect of hexadecasaccharide on the following markers:
-Post-PCI cardiac markers
-Inflammatory markers
-Coagulation activation markers
-Coagulation tests
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 12/01/2005
Contact:
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