Synergy Between Stent and Drugs to Avoid Ischemic Recurrences After Percutaneous Coronary Intervention (PRODIGY)

October 6, 2012 updated by: Marco Valgimigli

PROlonging Dual Antiplatelet Treatment In Patients With Coronary Artery Disease After Graded Stent-induced Intimal Hyperplasia studY

The duration of dual antiplatelet treatment (i.e. asprin and clopidogrel) after drug-eluting stent implantation is highly debated. This study will evaluate the value of extending such treatment up to 2 years after the procedure as compared to conventional treatment according to our national health institute guidelines (i.e. minimum 1 month after bare metal stent and 6 months after drug-eluting stent) on the composite endpoint of death, MI or stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, multi-center, open-label, study to evaluate the efficacy and safety profile of prolonged dual antiplatelet treatment (i.e. up to 2-year) with aspirin and clopidogrel after coronary stenting compared to currently recommended antiplatelet regimens (i.e. dual antiplatelet treatment for minimum 1 month after BMS or 6 months after DES implantation). As the degree of intimal hyperplasia (IH) suppression provided by the coronary stent system may be expected to influence the comparison between conventional versus prolonged dual antiplatelet treatment (DAT), patients in each group will be further randomized to no (BMS), intermediate (Endeavor), moderately high (Taxus) or very high (Xience V) degree of IH suppression so to minimize the confounding role of IH suppression on the primary hypothesis. Patients will be then follow-up on a clinical basis at 1, 6, 12, 18 and 24 months for the primary hypothesis and then every year up to five for secondary hypotheses.

In the conventional dual antiplatelet therapy group receiving one or more BMS implantation at the time of PCI, length of DAT may be influenced by acuity of clinical presentation. According to the CURE study (JAMA. 2002 Nov 20;288(19):2411-20), patients presenting with non-ST segment elevation acute coronary syndromes may be felt to require longer than 1 month DAT. Thus, to impose 1-month only of DAT duration after PCI may be not regarded as conventional at current stage. Based on this consideration, the protocol will allow extension of DAT up to 6 months after PCI in the conventional BMS group in those patients satisfying the inclusion and exclusion criteria of the CURE study at discretion of the treating physician.Extension of DAt up to 6 months after BMS in patients with STEMI is not recommended byt will be allowed as per protocol

Dual antiplatelet treatment refers to the use of Aspirin at doses ranging from 75 up to 325 mg/day p.o. in conjunction with clopidogrel (75 mg/day). Ticlopidine (250 mg/ twice a day) is a second-choice drug and it will be allowed in cases where clopidogrel is not well tolerated or unavailable. Clopidogrel and ticlopidine are equipotent antiplatelet agents. Both of them belong the class of thienopyridines and they act by inhibiting the the P2Y12 ADP receptor on platelets.

Study Type

Interventional

Enrollment (Anticipated)

1700

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Emilia Romagna
      • Ferrara, Emilia Romagna, Italy, 44100
        • Azienda Ospedaliera Universitaria di Ferrara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males or females ≥ 18 years of age with coronary artery disease with low, intermediate or high-risk coronary anatomy, which is considered suitable for PCI with stent placement.
  2. Subjects who have provided written informed consent prior to initiation of any study-related procedures, prior to receiving any pre-procedural sedation and who agree to comply with all protocol-specified procedures.

Exclusion Criteria:

  1. Women who are pregnant. Women of childbearing potential must have a negative pregnancy test (urine or serum HCG) within 7 days prior to randomization; as close to randomization as possible, within 24 hours preferred.
  2. Allergy or intolerance to aspirin, or both clopidogrel and ticlopidine

  3. Subjects with a contraindication to anticoagulation and/or increased bleeding risk:

    • Past or present bleeding disorder including a history of the following within 1 month prior to randomization: clinically relevant gastrointestinal bleeding, gross (visible) hematuria,
    • Planned major surgery including CABG after or within 1 month prior to randomization.
    • Any subject with a known coagulopathy, platelet disorder, or history of thrombocytopenia.
  4. Subjects with a history of cancer (limiting survival) not known to be disease free, with the exception of basal cell carcinoma of the skin.
  5. History of clinically important, recent or ongoing alcohol abuse or other drug abuse.
  6. Known platelet count <100,000/mm3 (<100 x 109/L).
  7. Subjects who is unable to give informed consent and assurance for complete contact through 2 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
treatment with Aspirin and clopidogrel for 24 months after coronary intervention with stents. This group of patients will be randomized in a 1:1:1:1 ratio to receive bare metal stent, Zotarolimus-eluting stent, paclitaxel-eluting stent or everolimus-eluting stent.
Drug: clopidogrel treatment after bare metal stent implantation
extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of bare metal stent
Other Names:
  • oral ADP receptor blockers
  • thienopyridines
Drug: clopidogrel treatment after bare metal stent implantation
Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 1 month after BMS implantation.
Other Names:
  • thienopyridines
  • Oral ADP receptor blocker
Drug: clopidogrel after zotarolimus-eluting stent implantation
extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of zotarolimus-eluting stent coronary implantation
Other Names:
  • ADP recepots blockers
  • p2y12 receptor blockers
Drug: clopidogrel after paclitaxel-eluting stent implantation
extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of paclitaxel-eluting stent
Other Names:
  • ADP receptor blockers
  • P2Y12 receptor blocker
Drug: clopidogrel after everolimus-eluting stent implantation
extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of Everolimus-eluting stent
Other Names:
  • ADP receptor blockers
  • P2Y12 receptor blocker
Drug: clopidogrel after zotarolimus-eluting stent implantation
Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 6 month after DES implantation.
Other Names:
  • ADP receptor blockers
  • P2Y12 receptor blocker
Drug: clopidogrel after paclitaxel-eluting stent implantation
Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 6 month after DES implantation.
Other Names:
  • ADP receptor blockers
  • P2Y12 receptor blockers
Drug: clopidogrel after everolimus-eluting stent implantation
Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 6 month after DES implantation.
Other Names:
  • ADP receptor blockers
  • P2Y12 receptor blockers
Active Comparator: 2
Treatment with aspirin and clopidogrel for minimum 1 or 6 month(s) after BMS or DES implantation, respectively. This group of patients will be randomized in a 1:1:1:1 ratio to receive bare metal stent, Zotarolimus-eluting stent, paclitaxel-eluting stent or everolimus-eluting stent
Drug: clopidogrel treatment after bare metal stent implantation
extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of bare metal stent
Other Names:
  • oral ADP receptor blockers
  • thienopyridines
Drug: clopidogrel treatment after bare metal stent implantation
Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 1 month after BMS implantation.
Other Names:
  • thienopyridines
  • Oral ADP receptor blocker
Drug: clopidogrel after zotarolimus-eluting stent implantation
extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of zotarolimus-eluting stent coronary implantation
Other Names:
  • ADP recepots blockers
  • p2y12 receptor blockers
Drug: clopidogrel after paclitaxel-eluting stent implantation
extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of paclitaxel-eluting stent
Other Names:
  • ADP receptor blockers
  • P2Y12 receptor blocker
Drug: clopidogrel after everolimus-eluting stent implantation
extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of Everolimus-eluting stent
Other Names:
  • ADP receptor blockers
  • P2Y12 receptor blocker
Drug: clopidogrel after zotarolimus-eluting stent implantation
Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 6 month after DES implantation.
Other Names:
  • ADP receptor blockers
  • P2Y12 receptor blocker
Drug: clopidogrel after paclitaxel-eluting stent implantation
Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 6 month after DES implantation.
Other Names:
  • ADP receptor blockers
  • P2Y12 receptor blockers
Drug: clopidogrel after everolimus-eluting stent implantation
Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 6 month after DES implantation.
Other Names:
  • ADP receptor blockers
  • P2Y12 receptor blockers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite of death, myocardial infarction or stroke occurring in the time window from 31 days and up to 24 months after intervention.
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the effect of intimal hyperplasia inhibition by drug-release (i.e. different stent types) on the composite of death and myocardial infarction 2 years after intervention
Time Frame: 24 months
24 months
Composite of death or myocardial infarction up to 24 months after intervention
Time Frame: 24 months
24 months
Cumulative incidence of Stent thrombosis according to the academic consortium definition after 30 days and up to 24 months after intervention
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marco Valgimigli

Investigators

  • Principal Investigator: Marco Valgimigli, MD, PhD, University of Ferrara, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

February 7, 2008

First Posted (Estimate)

February 8, 2008

Study Record Updates

Last Update Posted (Estimate)

October 10, 2012

Last Update Submitted That Met QC Criteria

October 6, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSD-03-I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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