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Author Notes:

Corresponding Author: Tanya N. Turan, MD MS, MUSC Stroke Program, 19 Hagood Avenue, Suite 501, Harborview Office Tower, Charleston, SC 29425, phone: 843-792-3020, fax: 843-792-2484, turan@musc.edu

Acknowledgments: The PACE self-assessment forms for smoking cessation and physical activity were provided by the San Diego Center for Health Interventions, LLC.

Vendors: INTERxVENT provides the lifestyle modification program to the study at a discounted rate.

The Veterans Affairs Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (Albuquerque, NM) handled the procurement, labeling, distribution, and inventory management of the study devices and rosuvastatin.

Walgreens pharmacies provide study medications except rosuvastatin to study patients at a discounted price (paid for by the study).

Disclosures: Drs. Turan, Derdeyn, Fiorella, Janis, and Chimowitz, and Michael Lynn MS, and Bethany Lane RN, MSN serve on the Executive Committee of the SAMMPRIS trial, which is funded by the National Institute of Neurological Disorders and Stroke (NINDS) (grant number: U01 NS058728).

All except Dr. Janis have received salary support from the SAMMPRIS grant.

Dr. Turan is currently supported by a NINDS K23 award (K23 NS069668).

Dr. Janis is the NINDS Program Officer for the trial.

Drs. Egan, Le, Lopes-Virella, Hermayer, Benavente, White, and Brown serve on the SAMMPRIS Risk Factor Committee and were reimbursed from the SAMMPRIS grant for these efforts.

Azhar Nizam MS serves at the Statistical Coordinating Center and receives salary support from the SAMMPRIS grant.

Michelle Caskey, Meghan Steiner, Nicole Vilardo and Andrew Stufflebean served in support roles for the Risk Factor Committee and received salary support from the SAMMPRIS grant for these efforts.

None of the authors have any financial relationship with the INTERxVENT Lifestyle Program.

See publication for full list of additional support.

Subjects:

Research Funding:

The SAMMPRIS trial was funded by a research grant (U01 NS058728) from the United States Public Health Service National Institute of Neurological Disorders and Stroke (NINDS).

In addition, Dr. Tanya Turan’s NIH-funded K23 grant award (1 K23 NS069668-01A1), provided support for her time and effort as the Director of Risk Factor Management.

Corporate Support: Stryker Neurovascular (formerly Boston Scientific Neurovascular) provided study devices and supplemental funding for third party device distribution, site monitoring and study auditing.

This research is also supported by the Investigator-Sponsored Study Program of AstraZeneca that donates rosuvastatin (Crestor) to study patients.

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Cardiac & Cardiovascular Systems
  • Cardiovascular System & Cardiology
  • stroke
  • cerebrovascular circulation
  • risk factors
  • atherosclerosis
  • lifestyle
  • TRANSIENT ISCHEMIC ATTACK
  • CORONARY-ARTERY-DISEASE
  • DENSITY-LIPOPROTEIN CHOLESTEROL
  • HEALTH-CARE PROFESSIONALS
  • HIGH-DOSE ATORVASTATIN
  • TREATMENT PANEL-III
  • CAROTID STENOSIS
  • DOUBLE-BLIND
  • CARDIOVASCULAR-DISEASE
  • PHYSICAL-ACTIVITY

Rationale, Design, and Implementation of Aggressive Risk Factor Management in the Stenting and Aggressive Medical Management for Prevention of Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) Trial

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Journal Title:

Circulation: Cardiovascular Quality and Outcomes

Volume:

Volume 5, Number 5

Publisher:

, Pages E51-E60

Type of Work:

Article | Post-print: After Peer Review

Abstract:

The value of comprehensive intensive atherosclerotic risk factor control in patients with coronary artery disease (CAD) is well-established. In 2007, the COURAGE trial demonstrated that among patients with stable coronary disease, intensive management of vascular risk factors was as good as endovascular intervention plus intensive medical management for preventing cardiac ischemic events1. Yet, despite the fact that atherosclerotic risk factor control in patients with stroke or TIA is recommended by guidelines2, a multimodal approach to prevention has not previously been tested in patients with atherosclerotic stroke. Older atherosclerotic-stroke prevention trials comparing carotid revascularization to medical therapy, such as NASCET3 and ACAS4, were performed in an era before statins and angiotensin converting enzyme (ACE) inhibitors became standard of care, and therefore risk factor control was not adequate by today’s standards. Even recent trials comparing carotid revascularization procedures5, 6 had little emphasis on risk factor control in their design and therefore had little impact on blood pressure and cholesterol measures at 1 year7, 8. Among stroke prevention trials in patients with heterogeneous causes of stroke, several trials have studied the effects of specific risk factor medications9–11 or of intensive control of a particular risk factor, such as blood pressure12, but no stroke prevention trials have used a muti-modal aggressive risk factor approach. Among patients with intracranial atherosclerosis, which may be the most common cause of stroke world-wide13, risk factor control is also believed to be important for stroke prevention. The Warfarin Aspirin Symptomatic Intracranial Disease (WASID) trial, in which patients with symptomatic intracranial stenosis were managed with either warfarin or aspirin and usual risk factor management14, showed that patients with poorly controlled blood pressure and elevated cholesterol during follow-up had significantly higher rates of recurrent stroke and other vascular events15, suggesting that aggressive management of vascular risk factors may benefit these patients. However, the impact of multi-modal aggressive risk factor control as a primary treatment strategy in patients with intracranial stenosis had not been assessed. Endovascular treatment of intracranial stenosis was also an emerging, yet unproven therapy. Therefore, in an effort to study these two treatment strategies, the Stenting and Aggressive Medical Management for Prevention of Recurrent stroke in Intracranial Stenosis (SAMMPRIS) Trial was designed to compare aggressive medical management alone versus aggressive medical management plus percutaneous transluminal angioplasty and stenting (PTAS). Thus, the SAMMPRIS trial became the first multicenter stroke prevention trial to encorporate multi-modal, protocol-driven risk factor control in the design. This paper focuses on the rationale, design, and implementation of the intensive risk factor management protocols in SAMMPRIS and describes challenges implementing these protocols during the trial and how the challenges have been managed.

Copyright information:

© 2012 American Heart Association, Inc.

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