GRAVITAS: Gauging Responsiveness With A VerifyNow Assay-Impact On Thrombosis And Safety

Acute Coronary Syndrome Clinical Trial

— GRAVITAS  

Official title:

GRAVITAS: Gauging Responsiveness With A VerifyNow Assay-Impact On Thrombosis And Safety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00645918
• Other study ID #: P95082
• 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
• 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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Myocardial Ischemia
• Thrombosis

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