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Aspirin Resistance and Percutaneous Coronary Intervention (PCI) (RESIST)

Primary Purpose

Stable Angina

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Intravenous Glycoprotein inhibitor + ASA, Clopidogrel

Antiplatelet Therapy (ASA, Clopidogrel)

About this trial

This is an interventional treatment trial for Stable Angina focused on measuring Major Adverse Cardiovascular Event, MACE, Death, MI, CK MB greater 3x Normal, Urgent Revascularization, Stent Thrombosis, Bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age older than 18 years
Scheduled for elective or ad-hos PCI
Aspirin use daily for greater or equal to one week
Aspirin resistant (ARU greater than or equal to 550 on Verify Now-ASA

Exclusion Criteria:

Pre-procedural elevation of cardiac biomarkers (CK-MB greater or equal to 10.4ng/dl or Tnl greater or equal to 0.4ng/dl
administration of any GP IIb/IIIa inhibitor, anticoagulation or lytic therapy in the previous 30 days
Ongoing bleeding or bleeding diathesis, contraindications for anticoagulation or increased bleeding risk or history of bleeding in the last eight weeks
Previous stroke or transient ischemic attack or any intracranial pathology in the last six months, major surgery or trauma within the previous six weeks
Platelet count less than hundred thousand per cubic millimeter or hematocrit <33% or hemoglobin <11 g per deciliter
Subjects who received full dose low molecular weight heparin within six hours prior to randomization
Allergy or intolerance to any of the study drugs or the presence of any serious comorbidity with life expectancy of ≤1year
Scheduled for saphenous vein graft intervention, chronic total occlusions or with impaired renal function (eGFR<60ml/min) or patients who were taking anticoagulants or antiplatelet agents other than aspirin and clopidogrel or nonsteroidal anti-inflammatory drugs within two weeks before the PCI procedure

Sites / Locations

Mount Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Conventional Strategy

Aggressive Strategy

Arm Description

Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure

Patient receive 325mg ASA orally and loading does of 600mg Clopidogrel at time of procedure with addition of IV GP IIb/IIIa inhibitor bolus intra procedurally

Outcomes

Primary Outcome Measures

Number of Participants With Elevation of Cardiac Enzyme

Number of participants with peri-procedural biomarker elevation defined as any elevation above baseline of CK-MB or Tn-I within 24 hours after completion of the procedure.

Secondary Outcome Measures

Number of Participants With Major Adverse Cardiac Event (MACE)

Number of participants with MACE which is any event of Death, MI, Stent Thrombosis, Urgent Revascularization, Bleeding. Major adverse cardiac events (MACE), defined as the composite of death, MI (CK-MB > 3 times normal), urgent revascularization and definite or probable stent thrombosis (ST) within 30 days. Stent thrombosis was defined according to the new academic research consortium definitions; 2) bleeding complications within 30 days. Major bleeding was defined as intracranial or intraocular bleeding or a drop in hemoglobin > 5 g/dL. Minor bleeding was defined as hemorrhage at the access site requiring intervention, hematoma with a diameter of at least 5 cm, a reduction in hemoglobin levels of at least 4 g/dL without an overt bleeding source or at least 3 g/dL with such a source, reoperation for bleeding or transfusion of a blood product.

Full Information

NCT ID

NCT01103440

First Posted

April 12, 2010

Last Updated

January 18, 2018

Sponsor

Icahn School of Medicine at Mount Sinai

1. Study Identification

Unique Protocol Identification Number

NCT01103440

Brief Title

Aspirin Resistance and Percutaneous Coronary Intervention (PCI)

Acronym

RESIST

Official Title

A Randomized, Pilot, Single-center Study, Investigator-Initiated Study to Look at an Aggressive Therapeutic Approach in Aspirin Resistant Patients Comparing to Standard for Patient Undergoing Percutaneous Coronary Intervention

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The objective of this study is to evaluate if aggressive antiplatelet therapy would reduce ischemic events in aspirin (ASA) resistant patients after percutaneous coronary intervention (PCI).

Detailed Description

This is the first US based randomized double blinded prospective study using triple antiplatelet therapy and double dose plavix maintenance dose in aspirin resistant patients undergoing elective PCI through femoral access. The primary outcome of this study is an elevation of cardiac enzymes within 24 hours after the PCI with a secondary outcome of a composite of major adverse cardiac events of death, MI, stent thrombosis and urgent revascularization and bleeding up to 30 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stable Angina

Keywords

Major Adverse Cardiovascular Event, MACE, Death, MI, CK MB greater 3x Normal, Urgent Revascularization, Stent Thrombosis, Bleeding

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Conventional Strategy

Arm Type

Other

Arm Description

Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure

Arm Title

Aggressive Strategy

Arm Type

Active Comparator

Arm Description

Patient receive 325mg ASA orally and loading does of 600mg Clopidogrel at time of procedure with addition of IV GP IIb/IIIa inhibitor bolus intra procedurally

Intervention Type

Drug

Intervention Name(s)

Intravenous Glycoprotein inhibitor + ASA, Clopidogrel

Other Intervention Name(s)

Cangrelor, Abciximab, Eptifibatide, Tirofiban

Intervention Description

IV Glycoprotein IIb/IIIa inhibitor bolus intra procedurally

Intervention Type

Drug

Intervention Name(s)

Antiplatelet Therapy (ASA, Clopidogrel)

Other Intervention Name(s)

Thienopyridines, Ticlopidine, Clopidogrel, Prasugrel

Intervention Description

Standard antiplatelet PCI treatment

Primary Outcome Measure Information:

Title

Number of Participants With Elevation of Cardiac Enzyme

Description

Number of participants with peri-procedural biomarker elevation defined as any elevation above baseline of CK-MB or Tn-I within 24 hours after completion of the procedure.

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Number of Participants With Major Adverse Cardiac Event (MACE)

Description

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age older than 18 years Scheduled for elective or ad-hos PCI Aspirin use daily for greater or equal to one week Aspirin resistant (ARU greater than or equal to 550 on Verify Now-ASA Exclusion Criteria: Pre-procedural elevation of cardiac biomarkers (CK-MB greater or equal to 10.4ng/dl or Tnl greater or equal to 0.4ng/dl administration of any GP IIb/IIIa inhibitor, anticoagulation or lytic therapy in the previous 30 days Ongoing bleeding or bleeding diathesis, contraindications for anticoagulation or increased bleeding risk or history of bleeding in the last eight weeks Previous stroke or transient ischemic attack or any intracranial pathology in the last six months, major surgery or trauma within the previous six weeks Platelet count less than hundred thousand per cubic millimeter or hematocrit <33% or hemoglobin <11 g per deciliter Subjects who received full dose low molecular weight heparin within six hours prior to randomization Allergy or intolerance to any of the study drugs or the presence of any serious comorbidity with life expectancy of ≤1year Scheduled for saphenous vein graft intervention, chronic total occlusions or with impaired renal function (eGFR<60ml/min) or patients who were taking anticoagulants or antiplatelet agents other than aspirin and clopidogrel or nonsteroidal anti-inflammatory drugs within two weeks before the PCI procedure

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Annapoorna S Kini, MD MRCP

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mount Sinai Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

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Aspirin Resistance and Percutaneous Coronary Intervention (PCI)

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