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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00645918
Other study ID # P95082
Secondary ID
Status Completed
Phase N/A
First received March 24, 2008
Last updated June 15, 2011
Start date June 2008
Est. completion date October 2010

Study information

Verified date June 2011
Source Accumetrics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the GRAVITAS trial is to determine whether tailored anti-platelet therapy using the Accumetrics VerifyNow P2Y12 assay reduces major adverse cardiovascular events after drug-eluting stent implantation.


Recruitment information / eligibility

Status Completed
Enrollment 2800
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Males or females aged 18 years or older.

- 2. Patients undergoing coronary angiography and possible PCI with planned use of at least one drug-eluting stent (DES), and without planned use of glycoprotein IIb/IIIa inhibitors. One or more bare metal stents (BMS) may be implanted, and other lesions may be treated without stenting, as long as at least one DES is implanted. However, the procedure must be successful and uncomplicated for all lesions (DES + BMS + non stent).

- Indication for the procedure may be stable angina or ischemia, unstable angina, non-ST elevation MI (NSTEMI), or ST elevation MI (STEMI).

- Have the ability to understand the requirements of the study, including consent for use and disclosure of research-related health information.

- Have the ability to comply with study procedures and protocol, including required study visits.

- 6. A female patient is eligible to enter the study if she is (1) of child-bearing potential and not pregnant or nursing; (2) not of child-bearing potential (i.e., has had a hysterectomy, have both ovaries removed, has tubal ligation, or are post-menopausal, defined as 24 months without menses).

Exclusion Criteria: Pre-PCI

- PCI within previous 30 days.

- Prior consent to participate in GRAVITAS and not randomized by IVRS.

- History of gastro-intestinal bleeding within 6 months.

- Major non-cardiac surgery within 6 weeks.

- Ischemic stroke within 6 weeks.

- Any history of hemorrhagic stroke or sub-arachnoid hemorrhage.

- Other bleeding diathesis, or considered by investigator to be at high-risk for bleeding on long-term clopidogrel therapy.

- Minor surgical procedures that require cessation of dual anti platelet therapy and result in significant bleeding are NOT eligible.

- Current or planned therapy with coumadin anticoagulation.

- Current or planned therapy with other thienopyridine class of ADP receptor inhibitors (e.g., prasugrel, ticlopidine), or the non-thienopyridine ticagrelor.

- Severe allergy to stainless steel, contrast dye, unfractionated heparin, low molecular weight heparin, or bivalirudin that cannot be adequately pre-medicated.

- Allergy to aspirin or clopidogrel.

- Current enrollment in an investigational drug or device study that has not reached the time period of the primary endpoint.

- Have received GPIIb/IIIa inhibitors eptifibatide or tirofiban within 24 hours before or during PCI or abciximab within 10 days before or during PCI.

- Thrombocytopenia (defined as platelet count < 100 K).

- Anemia (hematocrit < 30%).

- Polycythemia (hematocrit > 52%).

- Patients unwilling or unable to complete clinical follow-up for the duration of the study.

Exclusion Criteria: Post-PCI

- PCI with placement of at least one DES is not performed.

- Planned staged PCI in the next 6 months post-procedure.

- Unsuccessful PCI (post-procedure diameter stenosis >30% with less than TIMI-3 flow in any treated vessel).

- Patients with in-hospital STEMI confirmed by ECG prior to randomization or those whom require a target vessel revascularization of the index lesion prior to randomization.

- Patients with acute stent thrombosis before Accumetrics VerifyNow tests.

- Administration of any GPIIb/IIIa during PCI procedure or prior to initial hospital discharge.

- Failure to meet clopidogrel requirements

- Major complication during or after PCI

Study Design


Intervention

Drug:
clopidogrel
oral, 75 mg daily for 6 months starting on day of randomization
placebo
oral, 6 pill loading dose on day of randomization; one pill daily for 6 months starting on day of randomization
clopidogrel
oral, 450 mg loading dose on day of randomization; 75 mg daily for 6 months starting on day of randomization

Locations

Country Name City State
Canada Royal Alexandra Hospital Edmonton Alberta
Canada McMaster University Hamilton Ontario
Canada Centre Hospitalier de l'Université de Montréal (CHUM) Hôtel-Dieu Montréal Quebec
Canada Hôpital du Sacré-Coeur de Montréal Montréal Quebec
Canada Montréal Heart Institute Montréal Quebec
Canada Royal Victoria Hospital Montréal Quebec
Canada York PCI Group Newmarket Ontario
Canada University of Ottawa Heart Institute Ottawa Ontario
Canada Hôpital Laval Québec Quebec
Canada St. Michael's Hospital Toronto Ontario
United States AnMed Health Anderson South Carolina
United States St. Joseph's Research Institute Atlanta Georgia
United States Austin Heart P.A. Austin Texas
United States South Austin Hospital Austin Texas
United States Union Memorial Hospital Baltimore Maryland
United States University of Alabama at Birmingham Birmingham Alabama
United States Boston University Medical Center Boston Massachusetts
United States Bridgeport Hospital Bridgeport Connecticut
United States The Lahey Clinic Burlington Massachusetts
United States Medical University of South Carolina Charleston South Carolina
United States Jesse Brown VA Medical Center Chicago Illinois
United States University of Illinois Medical Center Chicago Illinois
United States The Lindner Clinical Trial Center Cincinnati Ohio
United States Clearwater Cardiovascular and Interventional Consultants Clearwater Florida
United States University Hospitals Case Medical Center Cleveland Ohio
United States Baylor Heart and Vascular Hospital Dallas Texas
United States Danbury Hospital Danbury Connecticut
United States Geisinger Clinic - Cardiology Danville Pennsylvania
United States St. Mary's Duluth Clinic Health System Duluth Minnesota
United States Durham VA Medical Center Durham North Carolina
United States North Ohio Research, Ltd. Elyria Ohio
United States St. Vincent Health Center Erie Pennsylvania
United States Cleveland Cardiovascular Research Foundation Fairview Park Ohio
United States Plaza Medical Center of Fort Worth Fort Worth Texas
United States Carolina Cardiology Associates High Point North Carolina
United States The Methodist Hospital Houston Texas
United States St. Vincent Heart Center of Indiana/The Care Group LLC Indianapolis Indiana
United States University of Florida Health Science Center Jacksonville Florida
United States St. Luke's / Mid America Heart Institute Kansas City Missouri
United States Scripps Green Hospital La Jolla California
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Trinity Medical Center Moline Illinois
United States El Camino Hospital Mountain View California
United States Centennial Medical Center Nashville Tennessee
United States Vanderbilt University Medical Center Nashville Tennessee
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Lenox Hill Hospital New York New York
United States NY Presbyterian / Weill Cornell Medical Center New York New York
United States Christiana Care Hospital Newark Delaware
United States Oklahoma Cardiovascular Associates Oklahoma City Oklahoma
United States University of Oklahoma Health Science Center Oklahoma City Oklahoma
United States Cardiology Research Associates Ormond Beach Florida
United States Cardiac and Vascular Research Center of Northern Michigan Petoskey Michigan
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States Hudson Valley Heart Center Poughkeepsie New York
United States Rhode Island Hospital Providence Rhode Island
United States The Miriam Hospital Providence Rhode Island
United States Wake Heart Research Raleigh North Carolina
United States Black Hills Clinical Research Center Rapid City South Dakota
United States Redmond Regional Medical Center Rome Georgia
United States William Beaumont Hospital Royal Oak Michigan
United States Sacramento Heart and Vascular Research Center Sacramento California
United States UC Davis Medical Center Sacramento California
United States University Hospital San Antonio (UTHSCSA) San Antonio Texas
United States Alvarado Hospital San Diego California
United States UCSD Medical Center San Diego California
United States San Francisco General Hospital San Francisco California
United States UCSF Moffitt-Long Hospital San Francisco California
United States Santa Barbara Cottage Hospital Santa Barbara California
United States Scottsdale Health Care - Osborn Campus Scottsdale Arizona
United States Scottsdale Health Care - Shea Campus Scottsdale Arizona
United States Baystate Medical Center Springfield Massachusetts
United States Prairie Education & Research Cooperative Springfield Illinois
United States Stony Brook University Medical Center Stony Brook New York
United States Washington Adventist Hospital Takoma Park Maryland
United States Tallahassee Memorial Hospital Tallahassee Florida
United States Tomball Regional Hospital Tomball Texas
United States Torrance Memorial Medical Center Torrance California
United States Washington Hospital Center Washington District of Columbia
United States Geisinger Wyoming Valley Medical Center Wilkes-Barre Pennsylvania
United States Wake Forest University Winston-Salem North Carolina
United States St. Joseph's Mercy Hospital Ypsilanti Michigan

Sponsors (1)

Lead Sponsor Collaborator
Accumetrics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to first occurrence of post-randomization CV death, non-fatal MI, or ARC definite/probable stent thrombosis in non-responders randomized to standard vs. tailored dosage 6 months
Secondary Time to first occurrence of post-randomization CV death, non-fatal MI, or ARC definite/probable stent thrombosis in non-responders randomized to standard dosage vs. responders 6 months
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