Effects of DES Platforms on Markers of Endothelial Damage and Inflammation (PLATFORM)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Francesco Pelliccia, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01489202
First received: December 6, 2011
Last updated: March 6, 2013
Last verified: March 2013
  Purpose

Percutaneous coronary intervention (PCI) with stenting may induce endothelial damage/dysfunction and inflammatory reactions, which in turn delay healing and endothelialization and may lead to restenosis and atherosclerosis within the stented segments. Drugs and polymers are considered the protagonists of these pathophysiologic processes whereas the role of stent platforms remains poorly defined.It remains unknown, conversely, if stent platforms affect the extent of post-PCI endothelial damage and inflammation.


Condition Intervention Phase
Coronary Artery Disease
Device: platinum chromium everolimus-eluting stent
Device: cobalt chromium everolimus-eluting stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Randomized Comparison of the Effects of PLatinum Chromium Everolimus-eluting Stent vs. cobAlT Chromium Everolimus-eluting Stent on inFlammatOry maRkers and Endothelial daMage - The PLATFORM Trial

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Post-PCI changes in markers of endothelial damage [ Time Frame: Baseline and 24 hours after PCI ] [ Designated as safety issue: No ]

    Changes 24 hours after PCI in the following indexes of endothelial damage:

    1. von Willebrand Factor (vWF)
    2. sE-selectin
    3. Vascular cell adhesion molecule (sVCAM-1)
    4. Intercellular adhesion molecule (sICAM-1)

  • Post-PCI changes in markers of inflammation [ Time Frame: Baseline and 24 hours after PCI ] [ Designated as safety issue: No ]

    Changes 24 hours after PCI in the following inflammatory markers:

    1. C-reactive protein (CPR)
    2. Fibrinogen
    3. Plasminogen activator inhibitor (PAI-1)
    4. Interleukin-6 (IL-6)


Secondary Outcome Measures:
  • 12-month rate of MACE [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    12-months incidence of major adverse cardiac events (MACE—death, myocardial infarction, target vessel revascularization)


Estimated Enrollment: 100
Study Start Date: September 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: platinum chromium EES
Patients undergoing PCI with stenting will have implantation of platinum chromium everolimus-eluting stents
Device: platinum chromium everolimus-eluting stent
An everolimus-eluting stent with a platinum chromium platform
Other Name: Promus ElementTM, Boston Scientific Corporation, Natick, MA, USA
Active Comparator: cobalt chromium everolimus-eluting stent
Patients undergoing PCI with stenting will have implantation of cobalt chromium everolimus-eluting stents
Device: cobalt chromium everolimus-eluting stent
An everolimus-eluting stent with cobalt chromium platform
Other Name: Xience VTM, Abbott Laboratories, Abbott Park, IL, USA

Detailed Description:

Percutaneous coronary intervention (PCI) with stenting may induce endothelial damage/dysfunction and inflammatory reactions, which in turn delay healing and endothelialization and may lead to restenosis and atherosclerosis within the stented segments.

Drugs and polymers are considered the protagonists of these pathophysiologic processes whereas the role of stent platforms remains poorly defined.

Due to advances in stent technology, stent platforms have evolved from the cobalt-chromium (CoCr) to the platinum-chromium (PtCr) stent series. At present, the PROMUS Element stent (which uses the PtCr platform) employs an identical polymer, drug, drug formulation and dose density to the CoCr XIENCE V stent.

The PLATINUM WH trial is the only randomized trial comparing the PROMUS Element stent with the XIENCE V stent in a total of 1,530 patients. The study met its primary end-point demonstrating that the PROMUS Element stent is non-inferior to the XIENCE V stent. The 12-month rare of target lesion failure was 3.4% in the PROMUS Element stent and 2.9% in the XIENCE V stent.

Pre-clinical animal studies, however, suggest that the PtCr platform might have important advantages over the CrCo platform, as improved vascular compatibility and early and late healing for PtCr devices compared with CoCr stents have been demonstrated.

In a rabbit denudation model, it was shown that at 14 days the luminal surface area is incompletely endothelialised with the CrCo stents but nearly complete for the PtCr stents. Similarly, another experimental study has shown that overall strut coverage, including endothelial cell coverage plus non-endothelial cell coverage (focal platelet and fibrin aggregates inter-mixed with red blood cells and inflammatory cells), is significantly lower at 14 days with the CoCr stent than with the PtCr OMEGA stent. Additionally, a recent investigation has shown that the thinner-strut PtCr stent is associated with reduced fibrin deposition and more rapid fibrin clearance in porcine coronary arteries compared with CrCo stent, thus suggesting that the PtCr stent platform may induce less injury compared with previous-generation platforms.

The primary objective of this study is to perform a randomized comparison of the biohumoral effects of platinum chromium everolimus-eluting stent (PtCr EES) vs. cobalt chromium everolimus-eluting stent (CoCr EES), i.e. stents with different platforms but identical drug and polymer.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A de novo native coronary artery lesions (reference vessel diameter:2.5-3.75 mm)
  • Class I indication to elective percutaneous coronary intervention
  • Stable conditions and no recent acute coronary syndromes
  • Normal baseline values of markers of myocardial damage (creatine kinase, creatine kinase-MB, myoglobin, and troponin I)
  • Able to understand and willing to sign the informed CF

Exclusion Criteria:

• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01489202

Contacts
Contact: Francesco Pelliccia, MD, PhD +393483392006 f.pelliccia@mclink.it
Contact: Cesare Greco, MD +39 335 8381320 cesare.greco@uniroma1.it

Locations
Italy
University La Sapienza Not yet recruiting
Rome, Italy, 00166
Principal Investigator: Francesco Pelliccia, MD, PhD         
Sponsors and Collaborators
University of Roma La Sapienza
  More Information

No publications provided by University of Roma La Sapienza

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Francesco Pelliccia, Assistant Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01489202     History of Changes
Other Study ID Numbers: 655/2011/D
Study First Received: December 6, 2011
Last Updated: March 6, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by University of Roma La Sapienza:
drug-eluting stent
percutaneous coronary intervention

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chromium
Cobalt
Everolimus
Sirolimus
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 29, 2014