Optimal Duration of Clopidogrel in Second-Generation Drug-Eluting Stents

NCT03056118 | Completed Phase 4 DMC

• 1 other identifier: 3-2011-0054
• Study Type: interventional
• Target: 1,368
• Locations: 0 countries
• Sites: N/A

Brief Summary

Investigators try to assess the safety of 6-months or 12-months maintenance of dual antiplatelet therapy (DAPT, aspirin + clopidogrel) in patients undergoing percutaneous coronary intervention using the Zotarolimus-eluting, Resolute Integrity™ stent (Medtronic Vascular Inc, Santa Rosa, CA) or the BioMatrix™ stent (Biosensors. Singapore).

Conditions

Ischemic Heart Disease

Keywords

OPTIMA-C

Outcome Measures

Primary Outcomes (1)

• A composite of major adverse cardiac events (MACE; cardiac death, target vessel MI and ischemia driven-target lesion revascularization; TLR)

  1. Cardiac death: Any death due to proximate cardiac cause (eg, MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death. 2. MI Classification and Criteria for Diagnosis is defined by the Academic Research Consortium 3. TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLRs should be classified prospectively as clinically indicated\* or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

  12 months

Study Arms (4)

6-month dual anti-platelet therapy

EXPERIMENTAL

maintain dual anti-platelet agents for 6 months

Drug: 6-month dual anti-platelet therapy

12-month dual anti-platelet therapy

ACTIVE COMPARATOR

maintain dual anti-platelet agents for 12 months

Drug: 12-month dual anti-platelet therapy

Zotarolimus eluting stent arm

ACTIVE COMPARATOR

implant with zotarolimus eluting stent (Resolute Integrity)

Device: Zotarolimus eluting stent

Biolimus eluting stent arm

ACTIVE COMPARATOR

implant with biolimus eluting stent (Biomatrix)

Device: Biolimus eluting stent

Interventions

6-month dual anti-platelet therapy DRUG

Aspirin and P2Y12 inhibitor after percutaneous coronary intervention continues for 6 months

Also known as: Aspirin and Clopidogrel

6-month dual anti-platelet therapy

12-month dual anti-platelet therapy DRUG

Aspirin and P2Y12 inhibitor after percutaneous coronary intervention continues for 12 months

Also known as: Aspirin and Clopidogrel

12-month dual anti-platelet therapy

Zotarolimus eluting stent DEVICE

Zotarolimus eluting stent is applied to coronary stenotic lesion

Zotarolimus eluting stent arm

Biolimus eluting stent DEVICE

Biolimus eluting stent is applied to coronary stenotic lesion

Biolimus eluting stent arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be at least 20 years of age.
• Subject must have evidence of myocardial ischemia (e.g. stable angina, non-ST elevation acute coronary syndrome, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia).
• Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving the Resolute Integrity or BioMatrix stent and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.

You may not qualify if:

• Acute ST elevation myocardial infarction
• The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, zotarolimus, biolimus, contrast media
• Clinical conditions requiring systemic immune suppression over 2 weeks or anti-cancer therapy
• Prior history of the following presentations: Thromboembolic disease, Stent thrombosis
• Pregnant women or women with childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
• History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
• Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
• Current known current platelet count \< 100,000 cells/mm3 or Hgb \<10 g/dL.
• Non-cardiac co-morbid conditions are present with life expectancy \< 1 year or that may result in protocol non-compliance (per site investigator's medical judgment
• Patients with left ventricular ejection fraction \< 35%
• Patients with cardiogenic shock
• Creatinine level \> 2.4mg/dL
• Severe hepatic dysfunction (aspartate aminotransferase and/or alanine aminotransferase ≥ 3 times upper normal reference values)

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Related Publications (1)

• Jang JY, Jung HW, Lee BK, Shin DH, Kim JS, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Park KW, Gwon HC, Kim HS, Kwon HM, Jang Y. Impact of PRECISE-DAPT and DAPT Scores on Dual Antiplatelet Therapy Duration After 2nd Generation Drug-Eluting Stent Implantation. Cardiovasc Drugs Ther. 2021 Apr;35(2):343-352. doi: 10.1007/s10557-020-07008-7.

  PMID: 32588238 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Dual Anti-Platelet Therapy; Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hyuck moon Kwon

  Gangnam Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 17, 2017
• Study Start: May 2, 2011
• Primary Completion: June 1, 2015
• Study Completion: September 7, 2015
• Last Updated: February 17, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share