Comparative Study of ALX-0081 Versus GPIIb/IIIa Inhibitor in High Risk Percutaneous Coronary Intervention (PCI) Patients

NCT01020383 | Completed Phase 2 DMC

• 1 other identifier: ALX-0081-2.1/09
• Study Type: interventional
• Target: 364
• Locations: 7 countries
• Sites: 39

Brief Summary

This is a multicenter, randomized and open-label Phase II study to compare the safety, tolerability and biological effectiveness of ALX-0081 versus the GPIIb/IIIa inhibitor ReoPro® in high risk PCI patients. Patients will receive standard treatment with acetylsalicylic acid (ASA) plus clopidogrel and heparin. Eligible patients will be randomly assigned to receive open-label study treatment with either ALX-0081 or ReoPro®. Patients will be stratified according to PCI type (elective or ad-hoc) and stent type (bare metal stent or drug eluting stent).

Conditions

Unstable Angina; Non ST Segment Elevation Myocardial Infarction (NSTEMI); Stable Angina (Associated With High Risk PCI)

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of bleeding classified by the following criteria: TIMI major bleeding events, TIMI minor bleeding events, bleeding events requiring medical attention, defined as TIMI minimal bleeding events

  30 days

Study Arms (2)

ALX-0081

EXPERIMENTAL

Drug: ALX-0081

GPIIb/IIIa inhibitor

ACTIVE COMPARATOR

Drug: ReoPro®

Interventions

ALX-0081 DRUG

4 i.v. bolus injections, once every 6 hours; first dose of 6 mg, three subsequent doses of 4 mg

ALX-0081

ReoPro® DRUG

0.25 mg/kg i.v. bolus injection followed by continuous i.v. infusion of 0.125 µg/kg/min (to a max. of 10 µg/min) for 12 hours

GPIIb/IIIa inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 and/or lesion/anatomy related: SYNTAX score \> 26, bifurcation lesions, multi-vessel disease, intracoronary thrombus.
• Adequate hematological function including platelets \> 100000/mm3.
• Body mass index (BMI) ≥18 kg/m2 and ≤ 35 kg/m2.
• Aged ≥ 18 years old.
• 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 first 4 months after treatment.
• Patients must be accessible for follow-up.
• Have a sufficient command to read and understand all instructions necessary for giving informed consent and participating in the study.
• Have signed and dated written informed consent prior to any study-related procedures.

You may not qualify if:

• Previous (within 30 days) treatment with GPIIb/IIIa inhibitors (such as ReoPro®).
• ST-elevation myocardial infarction (STEMI).
• Chronic total occlusion of a coronary artery.
• Scheduled rotablator procedure.
• PCI of the arterial or venous by-pass graft.
• Any contra-indication for ReoPro®.
• Major organ dysfunction, infection or any serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
• Known hypersensitivity to human/humanized antibodies.
• Women who are pregnant or lactating.
• Dementia or significantly altered mental status that would prohibit understanding the study procedures and giving informed consent.
• Use of vitamin K antagonists and/or Factor Xa inhibitors within 4 weeks prior to admission to the Hospital Intensive Care Unit.
• Use of GPIIa/IIIb inhibitors other than ReoPro®; prasugrel, bivalirudin and fondaparinux prior to and throughout the study.
• Known history of acquired or congenital bleeding disorder, coagulopathy or platelet disorder.
• Evidence of active pathological bleeding at screening or history of clinically significant bleeding (such as gastrointestinal or genitourinary) within the last 6 months prior to screening visit, unless the cause has been definitely corrected
• History of intracranial bleeding (e.g. hemorrhagic stroke, subdural hematoma, subarachnoid hemorrhage) or history of hemorrhagic retinopathy.

Sponsors & Collaborators

• Ablynx, a Sanofi company: lead

Study Sites (39)

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Graz, Austria

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Linz, Austria

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Vienna, Austria

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Aalst, Belgium

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Charleroi, Belgium

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Genk, Belgium

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Jette, Belgium

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Liège, Belgium

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Yvoir, Belgium

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Brno, Czechia

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Prague, Czechia

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Ústí nad Labem, Czechia

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Bad Nauheim, Germany

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Coburg, Germany

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Dortmund, Germany

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Hamburg, Germany

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Limburg, Germany

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Oldenburg, Germany

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Rostock, Germany

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Ashkelion, Israel

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Haifa, Israel

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Jerusalem, Israel

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Rehovot, Israel

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Tel Litwinsky, Israel

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Bielsko-Biala, Poland

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Dąbrowa Górnicza, Poland

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Gdynia, Poland

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Grodzisk Mazowiecki, Poland

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Katowice, Poland

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Kędzierzyn, Poland

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Kościerzyna, Poland

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Krakow, Poland

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Lódz, Poland

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Poznan, Poland

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Torun, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Lausanne, Switzerland

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Lugano, Switzerland

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MeSH Terms

Conditions

Angina, Unstable; Non-ST Elevated Myocardial Infarction; Angina, Stable

Interventions

caplacizumab; Abciximab

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis

Intervention Hierarchy (Ancestors)

Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Josefin-Beate Holz, MD

  Ablynx NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2009
• First Posted: November 24, 2009
• Study Start: September 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: March 1, 2012
• Last Updated: April 4, 2023

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share

Locations

IL (5); PL (13); CH (2); DE (7); CZ (3); AU (3); BE (6)