Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 46 of 507 for:    ASPIRIN AND P2

ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study (STOPDAPT-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02619760
Recruitment Status : Active, not recruiting
First Posted : December 2, 2015
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Takeshi Morimoto, Kyoto University, Graduate School of Medicine

Brief Summary:
The purpose of this study is to evaluate the safety of reducing dual antiplatelet therapy (DAPT) duration to 1 month after implantation of the everolimus-eluting cobalt-chromium stent (CoCr-EES).

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: 1-month DAPT Drug: 12-month DAPT Phase 4

Detailed Description:
The drug-eluting stents (DESs) are currently used in the majority of percutaneous coronary intervention (PCI) procedures. On the other hand, the problems of the first-generation DES (late adverse events, such as very late stent thrombosis) have been pointed out. Dual antiplatelet therapy (DAPT) has become a standard regimen after DES implantation and for fear of very late stent thrombosis, DAPT is frequently performed for 1 year or longer in clinical practice. However, serious hemorrhagic complications associated with a prolonged DAPT duration can bring disadvantages to patients, and it is extremely important to clarify an optimal DAPT duration after DES procedure. Currently, 1-month DAPT regimen after bare metal stent (BMS) implantation is commonly used in clinical practice, producing no major problems. Based on a meta-analysis of recent clinical studies, it has also been reported that the use of Cobalt-Chromium Everolimus-Eluting Stent (CoCr-EES) reduces the risk of early stent thrombosis by half compared to the use of BMS. There is no necessity to extend antiplatelet therapy after CoCr-EES implantation longer than after BMS implantation, and it is considered possible to use the same 1-month DAPT duration as after BMS implantation. We therefore planned a multicenter, randomized, open-label, controlled study, in which the subjects who have undergone CoCr-EES procedure will be diveded into the 1-month DAPT and clopidogrel monotherapy group and the 12-month DAPT and aspirin monotherapy group. Primary endpoint is the incidence of composite events including cardiovascular death, myocardial infarction, stent thrombosis, stroke, and bleeding defined by TIMI major or minor bleeding. At first, the non-inferiorty about primary endpoint of 1-month DAPT group will be evaluated at 12 months after index procedure and secondarily, the superiority about primary endpoint of 1-month DAPT group will be evaluated at 5 years after index procedure.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3045 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study
Actual Study Start Date : December 2015
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
Active Comparator: 1-month DAPT
1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists , followed by 59-month clopidogrel monotherapy
Drug: 1-month DAPT
1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists

Active Comparator: 12-month DAPT
1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists with 11-month DAPT composed of aspirin and clopidogrel, followed by 48-month aspirin monotherapy
Drug: 12-month DAPT
12-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists




Primary Outcome Measures :
  1. Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke/bleeding [ Time Frame: 12-month ]
    Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke/bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group


Secondary Outcome Measures :
  1. Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke [ Time Frame: 12-month ]
  2. Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke [ Time Frame: 60-month ]
  3. Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group [ Time Frame: 12-month ]
  4. Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group [ Time Frame: 60-month ]
  5. Upper gastrointestinal endoscopic examination or treatment [ Time Frame: 60-month ]
  6. Composite event of all-cause death/myocardial infarction [ Time Frame: 12-month ]
  7. Composite event of all-cause death/myocardial infarction [ Time Frame: 60-month ]
  8. All-cause death [ Time Frame: 12-month ]
  9. All-cause death [ Time Frame: 60-month ]
  10. Composite event of cardiovascular death/myocardial infarction [ Time Frame: 12-month ]
  11. Composite event of cardiovascular death/myocardial infarction [ Time Frame: 60-month ]
  12. Cardiovascular death [ Time Frame: 12-month ]
  13. Cardiovascular death [ Time Frame: 60-month ]
  14. Myocardial infarction [ Time Frame: 12-month ]
  15. Myocardial infarction [ Time Frame: 60-month ]
  16. Stroke [ Time Frame: 12-month ]
    a neurological deficit with acute onset that persists for at least 24 hours caused by a disturbance of the cerebral circulation due to ischemia or hemorrhage

  17. Stroke [ Time Frame: 60-month ]
    a neurological deficit with acute onset that persists for at least 24 hours caused by a disturbance of the cerebral circulation due to ischemia or hemorrhage

  18. MACE (Major Adverse Cardiac Events) [ Time Frame: 12-month ]
    Composite event of cardiac death, myocardial infarction and clinically-indicated target vesion revascularization

  19. MACE (Major Adverse Cardiac Events) [ Time Frame: 60-month ]
    Composite event of cardiac death, myocardial infarction and clinically-indicated target vesion revascularization

  20. Definite stent thrombosis [ Time Frame: 12-month ]
  21. Definite stent thrombosis [ Time Frame: 60-month ]
  22. Target lesion failure [ Time Frame: 12-month ]
    Composite event of cardiac death, myocardial infarction (MI) of target vessels, and Clinically-indicated TLR

  23. Target lesion failure [ Time Frame: 60-month ]
    Composite event of cardiac death, myocardial infarction (MI) of target vessels, and Clinically-indicated TLR

  24. Target vessel failure [ Time Frame: 12-month ]
  25. Target vessel failure [ Time Frame: 60-month ]
  26. Target lesion revasucularization [ Time Frame: 12-month ]
    PCI performed in the target lesion (within 5 mm of the stent edges), or CABG performed for restenosis of the target lesion or for treatment of other complications

  27. Target lesion revasucularization [ Time Frame: 60-month ]
    PCI performed in the target lesion (within 5 mm of the stent edges), or CABG performed for restenosis of the target lesion or for treatment of other complications

  28. Clinically-driven target lesion revascularization [ Time Frame: 12-month ]
    the revascularization that meets the following criteria; (1) recurrence of angina pectoris, presumably related to the target vessel, (2) objective signs of ischemia at rest or during exercise test (or equivalent), presumably related to the target vessel, (3) Signs of functional ischemia revealed by any invasive diagnostic test (e.g., Doppler flow velocity reserve [FVR], fractional flow reserve [FFR]), and (4) revascularization for ≥ 70% diameter stenosis even in the absence of the above-mentioned ischemic signs or symptoms. Presence/absence of clinical findings is judged by the operator of the procedure before the revascularization.

  29. Clinically-driven target lesion revascularization [ Time Frame: 60-month ]
    the revascularization that meets the following criteria; (1) recurrence of angina pectoris, presumably related to the target vessel, (2) objective signs of ischemia at rest or during exercise test (or equivalent), presumably related to the target vessel, (3) Signs of functional ischemia revealed by any invasive diagnostic test (e.g., Doppler flow velocity reserve [FVR], fractional flow reserve [FFR]), and (4) revascularization for ≥ 70% diameter stenosis even in the absence of the above-mentioned ischemic signs or symptoms. Presence/absence of clinical findings is judged by the operator of the procedure before the revascularization.

  30. Non target lesion revascularization [ Time Frame: 12-month ]
  31. Non target lesion revascularization [ Time Frame: 60-month ]
  32. Coronary artery bypass graft [ Time Frame: 12-month ]
  33. Coronary artery bypass graft [ Time Frame: 60-month ]
  34. Target vessel revascularization [ Time Frame: 12-month ]
  35. Target vessel revascularization [ Time Frame: 60-month ]
  36. Any coronary reascluarization [ Time Frame: 12-month ]
  37. Any coronary reascluarization [ Time Frame: 60-month ]
  38. Bleeding complications [ Time Frame: 12-month ]
    Evaluated with TIMI (major/minor/minimal), GUSTO (severe/moderate) and BARC (Type 1, 2, 3a, 3b, 3c, 4, 5a, 5b)

  39. Bleeding complications [ Time Frame: 60-month ]
    Evaluated with TIMI (major/minor/minimal), GUSTO (severe/moderate) and BARC (Type 1, 2, 3a, 3b, 3c, 4, 5a, 5b)

  40. Gastrointestinal bleeding [ Time Frame: 12-month ]
    Bleeding events requiring upper gastrointestinal endoscopic study or treatment.

  41. Gastrointestinal bleeding [ Time Frame: 60-month ]
    Bleeding events requiring upper gastrointestinal endoscopic study or treatment.

  42. Gastrointestinal complaints [ Time Frame: 12-month ]
    Symptoms requiring upper gastrointestinal endoscopic study or treatment

  43. Gastrointestinal complaints [ Time Frame: 60-month ]
    Symptoms requiring upper gastrointestinal endoscopic study or treatment



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients received percutaneous coronary intervention with cobalt-chromium everolimus-eluting stent
  • Patients who are capable of oral dual antiplatelet therapy consisting of asprin and P2Y12 receptor antagonist

Exclusion Criteria:

  • Patients requiring oral anticoagulants
  • Patients with medical history of intracranial hemorrhage
  • Patients who have experienced serious complications (myocardial infarction, stroke, and major bleeding) during hospital stay after percutaneous coronary intervention
  • Patients with drug eluting stents other than Cobalt chromium everolimus eluting stents (Xience) implanted at the time of enrollment
  • Patients comfirmed to have no tolerability to clopidgorel before enrollment
  • Patients requiring continuous administration of antiplaelet drugs other than aspirin and P2Y12 receptor antagonists at the time of enrollment
  • Patients with coronary bioabsorbable vascular scaffolds (BVS) implanted prior to or at the time of enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02619760


Locations
Layout table for location information
Japan
Division of Cardiology, Kyoto University Hospital
Kyoto, Japan, 606-8507
Sponsors and Collaborators
Kyoto University, Graduate School of Medicine
Investigators
Layout table for investigator information
Study Chair: Takeshi Kimura, MD, PhD Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Takeshi Morimoto, Professor of Medicine, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT02619760     History of Changes
Other Study ID Numbers: C1114
UMIN000019948 ( Other Identifier: UMIN )
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Keywords provided by Takeshi Morimoto, Kyoto University, Graduate School of Medicine:
Percutaneous Coronary Intervention
Platelet Aggregation Inhibitors
Additional relevant MeSH terms:
Layout table for MeSH terms
Aspirin
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents