Coronary Artery DiseasePhase 4PLATFORMNCT01489202
Effects of DES Platforms on Markers of Endothelial Damage and Inflammation
A Phase 4 study testing platinum chromium everolimus-eluting stent and cobalt chromium everolimus-eluting stent in people with Coronary Artery Disease, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- platinum chromium everolimus-eluting stent and cobalt chromium everolimus-eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2014to Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- platinum chromium everolimus-eluting stent, cobalt chromium everolimus-eluting stent
- Keywords
- drug-eluting stent, percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platinum chromium everolimus-eluting stentDevice
Also called Promus ElementTM, Boston Scientific Corporation, Natick, MA, USA
An everolimus-eluting stent with a platinum chromium platform
cobalt chromium everolimus-eluting stentDevice
Also called Xience VTM, Abbott Laboratories, Abbott Park, IL, USA
An everolimus-eluting stent with cobalt chromium platform
| Study group | Role | What they receive |
|---|---|---|
| platinum chromium EES | Active comparator | Patients undergoing PCI with stenting will have implantation of platinum chromium everolimus-eluting stents Receives: Device: platinum chromium everolimus-eluting stent |
| cobalt chromium everolimus-eluting stent | Active comparator | Patients undergoing PCI with stenting will have implantation of cobalt chromium everolimus-eluting stents Receives: Device: cobalt chromium everolimus-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-PCI changes in markers of endothelial damage
Changes 24 hours after PCI in the following indexes of endothelial damage:
- von Willebrand Factor (vWF)
- sE-selectin
- Vascular cell adhesion molecule (sVCAM-1)
- Intercellular adhesion molecule (sICAM-1)
Measured: Baseline and 24 hours after PCI
Post-PCI changes in markers of inflammation
Changes 24 hours after PCI in the following inflammatory markers:
- C-reactive protein (CPR)
- Fibrinogen
- Plasminogen activator inhibitor (PAI-1)
- Interleukin-6 (IL-6)
Measured: Baseline and 24 hours after PCI
Secondary outcomes (1)
12-month rate of MACE
12-months incidence of major adverse cardiac events (MACE-death, myocardial infarction, target vessel revascularization)
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2011 (estimated)
- Study startSep 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Pelliccia, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489202
- Sponsor's protocol ID
- 655/2011/D
- Acronym
- PLATFORM
- Status last verified
- Mar 2013
- First submitted
- 6 Dec 2011
- Last updated
- 7 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Pelliccia F, Del Prete G, Del Prete A, Greco C, Gaudio C. Effects of percutaneous coronary intervention and stenting with different drug-eluting coatings and platforms on endothelial damage and inflammation. Int J Cardiol. 2012 Apr 19;156(2):242-3. doi: 10.1016/j.ijcard.2012.01.059. Epub 2012 Feb 22. No abstract available.
PubMed 22360944
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01489202
- Acronym / sponsor ID
- PLATFORM / 655/2011/D
- Conditions
- Coronary Artery Disease
- Keywords
- drug-eluting stent, percutaneous coronary intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 9 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| platinum chromium EES | Active comparator | Device: platinum chromium everolimus-eluting stentPatients undergoing PCI with stenting will have implantation of platinum chromium everolimus-eluting stents |
| cobalt chromium everolimus-eluting stent | Active comparator | Device: cobalt chromium everolimus-eluting stentPatients undergoing PCI with stenting will have implantation of cobalt chromium everolimus-eluting stents |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| platinum chromium everolimus-eluting stentAlso: Promus ElementTM, Boston Scientific Corporation, Natick, MA, USAAn everolimus-eluting stent with a platinum chromium platform | Device | platinum chromium EES |
| cobalt chromium everolimus-eluting stentAlso: Xience VTM, Abbott Laboratories, Abbott Park, IL, USAAn everolimus-eluting stent with cobalt chromium platform | Device | cobalt chromium everolimus-eluting stent |
Primary outcome
Post-PCI changes in markers of endothelial damage
Time frame: Baseline and 24 hours after PCI
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
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)
1 secondary outcome
12-month rate of MACE
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2013.
- Derived from this study: PubMed 22360944Pelliccia F, Del Prete G, Del Prete A, Greco C, Gaudio C. Effects of percutaneous coronary intervention and stenting with different drug-eluting coatings and platforms on endothelial damage and inflammation. Int J Cardiol. 2012 Apr 19;156(2):242-3. doi: 10.1016/j.ijcard.2012.01.059. Epub 2012 Feb 22. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing platinum chromium everolimus-eluting stent and cobalt chromium everolimus-eluting stent in people with Coronary Artery Disease, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Pelliccia, MD, PhD (+393483392006, f.pelliccia@mclink.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-PCI changes in markers of endothelial damage (time frame: Baseline and 24 hours after PCI). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01489202, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2013.