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Clinical Trials/EUCTR2009-012206-39-DE
EUCTR2009-012206-39-DE
Active, not recruiting
Not Applicable

A phase II randomized, open label clinical trial in high risk percutaneous coronary intervention (PCI) patients receiving standard antithrombotic treatment plus either ALX-0081 or GPIIb/IIIa inhibitor (ReoPro®) over a period of 24 hours

Ablynx0 sites368 target enrollmentAugust 17, 2009
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ConditionsThrombotic events associated with percutaneous coronary intervention (PCI) in patients with unstable angina or Non ST-Segment Elevation Myocardial Infarction (NSTEMI), or stable angina with at least 2 factors indicating a high risk PCI.MedDRA version: 9.1Level: LLTClassification code 10011076Term: Coronary artery atherosclerosisMedDRA version: 9.1Level: LLTClassification code 10011078Term: Coronary artery diseaseMedDRA version: 9.1Level: LLTClassification code 10013210Term: Disorder coronary arteryMedDRA version: 9.1Level: LLTClassification code 10063933Term: Coronary stent thrombosisMedDRA version: 9.1Level: LLTClassification code 10065608Term: Percutaneous coronary interventionMedDRA version: 9.1Level: LLTClassification code 10003211Term: Arteriosclerosis coronary arteryMedDRA version: 9.1Level: LLTClassification code 10011067Term: Coronary angiogram abnormalMedDRA version: 9.1Level: LLTClassification code 10011093Term: Coronary atherosclerosisMedDRA version: 9.1Level: LLTClassification code 10011099Term: Coronary diseaseMedDRA version: 9.1Level: LLTClassification code 10051592Term: Acute coronary syndrome
DrugsReoPro

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thrombotic events associated with percutaneous coronary intervention (PCI) in patients with unstable angina or Non ST-Segment Elevation Myocardial Infarction (NSTEMI), or stable angina with at least 2 factors indicating a high risk PCI.
Sponsor
Ablynx
Enrollment
368
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 17, 2009
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Ablynx

Eligibility Criteria

Inclusion Criteria

  • •1\.Have unstable angina or NSTEMI, or stable angina with at least 2 factors indicating a high risk PCI as follows:
  • •\-patient related: diabetic patients, renal failure (glomerular filtration rate \< 60\), reduced left ventricular ejection fraction \< 35%, age \> 75 years, female gender
  • •\-lesion/anatomy related: SYNTAX score \> 26, bifurcation lesions, multi\-vessel disease, intracoronary thrombus.
  • •2\.Adequate hematological function including platelets \> 100000/mm3\.
  • •3\.Body mass index (BMI) \=18 kg/m2 and \= 35 kg/m2\.
  • •4\.Aged \= 18 years old.
  • •5\.Women of childbearing potential must be practicing a medically acceptable contraceptive regimen. Only males who do not want to father children during the study and in the first 4 months after treatment may be included in the study. During this period, safe contraception is mandatory. Male patients who are sexually active must use a condom during intercourse and ensure that the female partner uses a reliable contraceptive method, or they must refrain from sexual intercourse during the entire clinical study. As reliable contraceptive methods for female partners the following measures are accepted:
  • •Hormonal contraception (e.g. pill, depot injection)
  • •Intrauterine device
  • •Diaphragm with spermicide

Exclusion Criteria

  • •1\.Previous (within 30 days) treatment with GPIIb/IIIa inhibitors (such as ReoPro®).
  • •2\.ST\-elevation myocardial infarction (STEMI).
  • •3\.Chronic total occlusion of a coronary artery.
  • •4\.Scheduled rotablator procedure.
  • •5\.PCI of the arterial or venous by\-pass graft.
  • •6\.Any contra\-indication for ReoPro®.
  • •7\.Major organ dysfunction, infection or any serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
  • •8\.Known hypersensitivity to human/humanized antibodies.
  • •9\.Women who are pregnant or lactating.
  • •10\.Dementia or significantly altered mental status that would prohibit understanding the study procedures and giving informed consent.

Outcomes

Primary Outcomes

Not specified

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