NCT00533039

Brief Summary

As evidence accumulates that atherogenesis or Coronary Artery Disease (CAD) may not be simply a disorder of lipid metabolism, but an inflammatory disease, the focus of treatment has shifted. A-002 or Varespladib is an anti-inflammatory drug for treatment of chronic and acute diseases. It acts by inhibiting secretory phospholipase A2 (sPLA2 ) - one of a family of enzymes leading to inflammation - which may be important in: 1) the development of atherosclerosis and 2) the increase in occurence of cardiovascular events after angioplasty. Previous studies have demonstrated that sPLA2: 1) facilitates the pro-atherogenic effects of low-density (LDL or bad cholesterol) and 2) increased levels post-angioplasty correlate with an increased risk of events at followup contact. Therefore this study proposes to investigate the ability of A-002 to prevent or reduce myocardial damage after angioplasty by inhibiting the cascade of inflammatory mediators. Substudy - Subjects who agree will also have a vascular ultrasound 24h post-PCI to assess endothelial function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P50-P75 for phase_2 coronary-artery-disease

Timeline
Completed

Started Oct 2007

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

First Submitted

Initial submission to the registry

September 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2007

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

October 9, 2009

Status Verified

June 1, 2008

Enrollment Period

1.7 years

First QC Date

September 19, 2007

Last Update Submit

October 8, 2009

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint will be incidence of myocardial injury as evidenced by elevation of CK-MB or troponin I above the upper limit of normal.

    8 hours and 18-24 hours post-angioplasty

Secondary Outcomes (3)

  • A secondary endpoint will be occurrence of elevation of CK-MB or troponin I above the upper limit of normal.

    8 and 18-24 hours post-angioplasty

  • A secondary endpoint will be occurrence of any major adverse cardiac events (MACE).

    30 days post-angioplasty

  • A secondary outcome will be serum sPLA2 activity.

    5-7 days post-angioplasty

Study Arms (2)

Control

PLACEBO COMPARATOR

Subjects take 2 tablets BID. Placebo tablets are identical to active medication.

Drug: placebo

Varespladib (A-002)

EXPERIMENTAL

Subjects take 250mg tablets BID beginning 3-5 days pre-angioplasty and for 5 days post-angioplasty.

Drug: Varespladib (A-002)

Interventions

Varespladib (A-002)DRUG

250mg tablets BID for 3-5 days pre-angioplasty and 5 days post-angioplasty.

Varespladib (A-002)
placeboDRUG

250mg tablets BID 3-5 days pre-angioplasty and 5 days post-angioplasty.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women ≥ 18 years of age undergoing elective PCI, with or without stenting

You may not qualify if:

  • ST elevation MI or any troponin elevation (non-STEMI) within preceding 10days
  • Elevation of CK-MB or troponin I at baseline
  • Recent (4 weeks) coronary bypass surgery
  • NYHA class III-IV heart failure
  • Left ventricular ejection fraction \< 0.30
  • Severe valvular heart disease
  • Chronic inflammatory disease (e.g., lupus, rheumatoid arthritis, inflammatory bowel disease), or patients receiving steroid drugs
  • Presence of severe liver disease with cirrhosis
  • Recent active hepatitis
  • Active chronic hepatitis
  • ALT or AST \> 3 × upper limit of normal (ULN)
  • Biliary obstruction with hyperbilirubinemia (total bilirubin \> 2 × ULN)
  • Moderate or severe renal impairment (creatinine \> 1.5 × ULN)
  • Nephrotic syndrome or subjects undergoing dialysis
  • Uncontrolled diabetes (HbA1c \> 11% 1 month prior to screening)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

  • Dzavik V, Lavi S, Thorpe K, Yip PM, Plante S, Ing D, Overgaard CB, Osten MD, Lan J, Robbins K, Miner SE, Horlick EM, Cantor WJ. The sPLA2 Inhibition to Decrease Enzyme Release after Percutaneous Coronary Intervention (SPIDER-PCI) trial. Circulation. 2010 Dec 7;122(23):2411-8. doi: 10.1161/CIRCULATIONAHA.110.950733. Epub 2010 Nov 22.

    PMID: 21098449DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

varespladibvarespladib methyl

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Vladimir Dzavik, MD

    University Health Network, Toronto

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 19, 2007

First Posted

September 21, 2007

Study Start

October 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

October 9, 2009

Record last verified: 2008-06

Locations

CA(1)