NCT01269242

Brief Summary

The main study objective is to assess the efficacy and safety of different bindarit dosages compared to placebo in preventing restenosis, in patients submitted to coronary stenting and using a bare metal stent (Vision BMS, by Abbott).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

August 5, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

January 3, 2011

Last Update Submit

August 4, 2016

Conditions

Coronary Restenosis

Keywords

coronary restenosisangioplastystentMCP-1/CCL2MCP-3/CCL7

Outcome Measures

Primary Outcomes (1)

  • in-segment late loss (in-stent and 5 mm proximally and distally to the stent) measured by QCA

    Late loss is defined as the difference between post-procedural minimum lumen diameter and 6-month minimum lumen diameter measured in-stent and in-segment.

    6 months from the index procedure

Secondary Outcomes (4)

  • Major Adverse Cardiac Events (MACE)

    9 months

  • the assessment of the safety profile of the two bindarit dosages compared to placebo

    9 months

  • the imaging parameters evaluated with OCT as an optional procedure performed on a subgroup of patients.

    6 months from the index procedure

  • the assessment of inflammatory biomarkers in order to investigate the bindarit mechanism of action.

    9 months

Study Arms (3)

bindarit 600 mg

EXPERIMENTAL
Drug: bindarit

bindarit 1200 mg

EXPERIMENTAL
Drug: bindarit

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

bindaritDRUG

300 mg bid, that is one 300 mg tablet twice a day for 6 months;

bindarit 600 mg
placeboDRUG

bindarit-matching placebo tablets for 6 months.

placebo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients with no limitation of race, \> 18 years of age (or minimum age as required by local regulations). Female patients of childbearing potential, required to have a negative pregnancy test and use a birth control method. Oral contraceptive are not allowed.
  • Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I,II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II-III), or patients with documented silent ischemia.
  • Maximum of two de novo lesions (\>70% stenosis) per patients, to be treated with no other planned procedure within six months from the index intervention.
  • Patients eligible for the placement of the Vision (Abbott) bare metal stent.
  • The patient willing and able to cooperate with the protocol procedures, particularly attending the scheduled visits.
  • Patients legally able to give written informed consent to the trial.
  • A written informed consent to the trial signed and dated by the patient is available.

You may not qualify if:

  • Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drugs such the study medication, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media, or with a positive history for drug allergy.
  • Lesions in venous or arterial grafts.
  • Total occlusions.
  • In-stent restenosis.
  • Unprotected Left Main lesions.
  • Acute myocardial infarction (ST elevation and/or Non ST Elevation) in the 48 hours prior to the procedure.
  • Women with known pregnancy or who are lactating.
  • Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated.
  • Current medical condition with a life expectancy of less than 24 months.
  • The subject is participating in another device or drug study. Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrolment in this trial.
  • Patients under the influence of alcohol or narcotics.
  • Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this registry.
  • m. Potassium value above the upper limit normal range.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione S.Raffaele del Monte Tabor - UO Emodinamica e Cardiologia Interventistica

Milan, Milan, 20132, Italy

Location

Related Links

MeSH Terms

Conditions

Coronary Restenosis

Interventions

bindarit

Condition Hierarchy (Ancestors)

Coronary StenosisCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Antonio Colombo, MD

    Fondazione S.Raffaele del Monte Tabor - U.O Emodinamica e Cardiologia Interventistica

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2011

First Posted

January 4, 2011

Study Start

January 1, 2009

Primary Completion

January 1, 2011

Study Completion

April 1, 2011

Last Updated

August 5, 2016

Record last verified: 2016-08

Locations

IT(1)