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AzTrials

Coronary Artery DiseasePhase 4PRODIGYNCT00611286

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

A Phase 4 study testing clopidogrel treatment after bare metal stent implantation, clopidogrel after zotarolimus-eluting stent implantation and clopidogrel after paclitaxel-eluting stent implantation in people with Coronary Artery Disease, run by Marco Valgimigli at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
clopidogrel treatment after bare metal stent implantation, clopidogrel after zotarolimus-eluting stent implantation and clopidogrel after paclitaxel-eluting stent implantation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,700 participants
Where
1 siteItaly
Study dates
Dec 2006to Oct 2012
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.

Who cannot join

  • 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.
  • Allergy or intolerance to aspirin, or both clopidogrel and ticlopidine
  • 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.
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  • Subjects with a history of cancer (limiting survival) not known to be disease free, with the exception of basal cell carcinoma of the skin.
  • History of clinically important, recent or ongoing alcohol abuse or other drug abuse.
  • Known platelet count <100,000/mm3 (<100 x 109/L).
  • Subjects who is unable to give informed consent and assurance for complete contact through 2 years.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Azienda Ospedaliera Universitaria di Ferrara

    Ferrara, Emilia-Romagna, 44100

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Being tested
clopidogrel treatment after bare metal stent implantation, clopidogrel after zotarolimus-eluting stent implantation, clopidogrel after paclitaxel-eluting stent implantation, clopidogrel after everolimus-eluting stent implantation
Keywords
Drug-eluting stent, clopidogrel, bare metal stent, landmark analysis, Patients with coronary artery disease
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.

  • clopidogrel treatment after bare metal stent implantationDrug

    Also called oral ADP receptor blockers, thienopyridines

    extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of bare metal stent

  • clopidogrel treatment after bare metal stent implantationDrug

    Also called Oral ADP receptor blocker, thienopyridines

    Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 1 month after BMS implantation.

  • clopidogrel after zotarolimus-eluting stent implantationDrug

    Also called ADP recepots blockers, p2y12 receptor blockers

    extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of zotarolimus-eluting stent coronary implantation

  • clopidogrel after paclitaxel-eluting stent implantationDrug

    Also called ADP receptor blockers, P2Y12 receptor blocker

    extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of paclitaxel-eluting stent

  • clopidogrel after everolimus-eluting stent implantationDrug

    Also called ADP receptor blockers, P2Y12 receptor blocker

    extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of Everolimus-eluting stent

  • clopidogrel after zotarolimus-eluting stent implantationDrug

    Also called ADP receptor blockers, P2Y12 receptor blocker

    Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 6 month after DES implantation.

  • clopidogrel after paclitaxel-eluting stent implantationDrug

    Also called ADP receptor blockers, P2Y12 receptor blockers

    Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 6 month after DES implantation.

  • clopidogrel after everolimus-eluting stent implantationDrug

    Also called ADP receptor blockers, P2Y12 receptor blockers

    Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 6 month after DES implantation.

Study groups in NCT00611286
Study groupRoleWhat they receive
1Experimentaltreatment 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.
Receives: 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
2Active comparatorTreatment 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
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 24 months

Secondary outcomes (3)

  1. 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

    Measured: 24 months

  2. Composite of death or myocardial infarction up to 24 months after intervention

    Measured: 24 months

  3. Cumulative incidence of Stent thrombosis according to the academic consortium definition after 30 days and up to 24 months after intervention

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2008 (estimated)
  2. Study startDec 2006
  3. Primary completionDec 2010
  4. Study completionOct 2012

Resources

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
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
1,700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00611286
Sponsor's protocol ID
SSD-03-I
Acronym
PRODIGY
Status last verified
Oct 2012
First submitted
26 Dec 2007
Last updated
10 Oct 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

    PubMed 35224730

  • Gargiulo G, Heg D, Ferrari F, Percoco G, Campo G, Tumscitz C, Colombo F, Zuffi A, Castriota F, Cremonesi A, Windecker S, Valgimigli M. Stent and Dual Antiplatelet Therapy Duration Comparisons in the Setting of a Multicenter Randomized Controlled Trial: Can the Operator Experience Affect the Study Results? J Am Heart Assoc. 2017 Dec 23;6(12):e007150. doi: 10.1161/JAHA.117.007150.

    PubMed 29275371

  • Piccolo R, Gargiulo G, Franzone A, Santucci A, Ariotti S, Baldo A, Tumscitz C, Moschovitis A, Windecker S, Valgimigli M. Use of the Dual-Antiplatelet Therapy Score to Guide Treatment Duration After Percutaneous Coronary Intervention. Ann Intern Med. 2017 Jul 4;167(1):17-25. doi: 10.7326/M16-2389. Epub 2017 Jun 13.

    PubMed 28605779

  • Franzone A, Piccolo R, Gargiulo G, Ariotti S, Marino M, Santucci A, Baldo A, Magnani G, Moschovitis A, Windecker S, Valgimigli M. Prolonged vs Short Duration of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With or Without Peripheral Arterial Disease: A Subgroup Analysis of the PRODIGY Randomized Clinical Trial. JAMA Cardiol. 2016 Oct 1;1(7):795-803. doi: 10.1001/jamacardio.2016.2811.

    PubMed 27572001

  • Gargiulo G, Costa F, Ariotti S, Biscaglia S, Campo G, Esposito G, Leonardi S, Vranckx P, Windecker S, Valgimigli M. Impact of proton pump inhibitors on clinical outcomes in patients treated with a 6- or 24-month dual-antiplatelet therapy duration: Insights from the PROlonging Dual-antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY trial. Am Heart J. 2016 Apr;174:95-102. doi: 10.1016/j.ahj.2016.01.015. Epub 2016 Jan 25.

    PubMed 26995375

  • Costa F, Tijssen JG, Ariotti S, Giatti S, Moscarella E, Guastaroba P, De Palma R, Ando G, Oreto G, Zijlstra F, Valgimigli M. Incremental Value of the CRUSADE, ACUITY, and HAS-BLED Risk Scores for the Prediction of Hemorrhagic Events After Coronary Stent Implantation in Patients Undergoing Long or Short Duration of Dual Antiplatelet Therapy. J Am Heart Assoc. 2015 Dec 7;4(12):e002524. doi: 10.1161/JAHA.115.002524.

    PubMed 26643501

  • Costa F, Adamo M, Ariotti S, Ferrante G, Navarese EP, Leonardi S, Garcia-Garcia H, Vranckx P, Valgimigli M. Left main or proximal left anterior descending coronary artery disease location identifies high-risk patients deriving potentially greater benefit from prolonged dual antiplatelet therapy duration. EuroIntervention. 2016 Feb;11(11):e1222-30. doi: 10.4244/EIJY15M08_04.

    PubMed 26342472

  • Costa F, Vranckx P, Leonardi S, Moscarella E, Ando G, Calabro P, Oreto G, Zijlstra F, Valgimigli M. Impact of clinical presentation on ischaemic and bleeding outcomes in patients receiving 6- or 24-month duration of dual-antiplatelet therapy after stent implantation: a pre-specified analysis from the PRODIGY (Prolonging Dual-Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia) trial. Eur Heart J. 2015 May 21;36(20):1242-51. doi: 10.1093/eurheartj/ehv038. Epub 2015 Feb 25.

    PubMed 25718355

  • Valgimigli M, Tebaldi M, Borghesi M, Vranckx P, Campo G, Tumscitz C, Cangiano E, Minarelli M, Scalone A, Cavazza C, Marchesini J, Parrinello G; PRODIGY Investigators. Two-year outcomes after first- or second-generation drug-eluting or bare-metal stent implantation in all-comer patients undergoing percutaneous coronary intervention: a pre-specified analysis from the PRODIGY study (PROlonging Dual Antiplatelet Treatment After Grading stent-induced Intimal hyperplasia studY). JACC Cardiovasc Interv. 2014 Jan;7(1):20-8. doi: 10.1016/j.jcin.2013.09.008. Epub 2013 Dec 11.

    PubMed 24332420

  • Campo G, Tebaldi M, Vranckx P, Biscaglia S, Tumscitz C, Ferrari R, Valgimigli M. Short- versus long-term duration of dual antiplatelet therapy in patients treated for in-stent restenosis: a PRODIGY trial substudy (Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia). J Am Coll Cardiol. 2014 Feb 18;63(6):506-12. doi: 10.1016/j.jacc.2013.09.043. Epub 2013 Oct 23.

    PubMed 24161321

  • Valgimigli M, Borghesi M, Tebaldi M, Vranckx P, Parrinello G, Ferrari R; PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY Investigators. Should duration of dual antiplatelet therapy depend on the type and/or potency of implanted stent? A pre-specified analysis from the PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY (PRODIGY). Eur Heart J. 2013 Mar;34(12):909-19. doi: 10.1093/eurheartj/ehs460. Epub 2013 Jan 12.

    PubMed 23315904

  • Valgimigli M, Campo G, Monti M, Vranckx P, Percoco G, Tumscitz C, Castriota F, Colombo F, Tebaldi M, Fuca G, Kubbajeh M, Cangiano E, Minarelli M, Scalone A, Cavazza C, Frangione A, Borghesi M, Marchesini J, Parrinello G, Ferrari R; Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia Study (PRODIGY) Investigators. Short- versus long-term duration of dual-antiplatelet therapy after coronary stenting: a randomized multicenter trial. Circulation. 2012 Apr 24;125(16):2015-26. doi: 10.1161/CIRCULATIONAHA.111.071589. Epub 2012 Mar 21.

    PubMed 22438530

  • Valgimigli M, Campo G, Percoco G, Monti M, Ferrari F, Tumscitz C, Zuffi A, Colombo F, Kubbajeh M, Cavazza C, Cangiano E, Tebaldi M, Minarelli M, Arcozzi C, Scalone A, Frangione A, Borghesi M, Marchesini J, Parrinello G, Ferrari R. Randomized comparison of 6- versus 24-month clopidogrel therapy after balancing anti-intimal hyperplasia stent potency in all-comer patients undergoing percutaneous coronary intervention Design and rationale for the PROlonging Dual-antiplatelet treatment after Grading stent-induced Intimal hyperplasia study (PRODIGY). Am Heart J. 2010 Nov;160(5):804-11. doi: 10.1016/j.ahj.2010.07.034.

    PubMed 21095265

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing clopidogrel treatment after bare metal stent implantation, clopidogrel after zotarolimus-eluting stent implantation and clopidogrel after paclitaxel-eluting stent implantation in people with Coronary Artery Disease, run by Marco Valgimigli 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 2 inclusion and 10 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: finished, as of the sponsor's last update on 10 Oct 2012. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). 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 NCT00611286, which also lists 13 linked publications.

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 10 Oct 2012.

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