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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marco Valgimigli, Università degli Studi di Ferrara
ClinicalTrials.gov Identifier:
NCT00611286
First received: December 26, 2007
Last updated: October 6, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Drug: clopidogrel treatment after bare metal stent implantation
Drug: clopidogrel after zotarolimus-eluting stent implantation
Drug: clopidogrel after paclitaxel-eluting stent implantation
Drug: clopidogrel after everolimus-eluting stent implantation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PROlonging Dual Antiplatelet Treatment In Patients With Coronary Artery Disease After Graded Stent-induced Intimal Hyperplasia studY

Resource links provided by NLM:


Further study details as provided by Università degli Studi di Ferrara:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Composite of death or myocardial infarction up to 24 months after intervention [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1700
Study Start Date: December 2006
Study Completion Date: October 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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
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
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:
  • Oral ADP receptor blocker
  • thienopyridines
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00611286

Locations
Italy
Azienda Ospedaliera Universitaria di Ferrara
Ferrara, Emilia Romagna, Italy, 44100
Sponsors and Collaborators
Marco Valgimigli
Investigators
Principal Investigator: Marco Valgimigli, MD, PhD University of Ferrara, Italy
  More Information

No publications provided by Università degli Studi di Ferrara

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Marco Valgimigli, Head of the Catheterization laboratory, Università degli Studi di Ferrara
ClinicalTrials.gov Identifier: NCT00611286     History of Changes
Other Study ID Numbers: SSD-03-I
Study First Received: December 26, 2007
Last Updated: October 6, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Università degli Studi di Ferrara:
Drug-eluting stent
clopidogrel
bare metal stent
landmark analysis
Patients with coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Paclitaxel
Sirolimus
Everolimus
Clopidogrel
Ticlopidine
Purinergic P2Y Receptor Antagonists
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014