Cardiovascular Disease Clinical Trial
— SPARCLOfficial title:
A Double-Blind, Randomized, Placebo- Controlled Study Of Atorvastatin As Prevention Of Cerebrovascular Events In Patients With A Previous Transient Ischemic Attack (TIA) Or Stroke
| Verified date | April 2015 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
To determine whether Lipitor reduces stroke, compared to placebo in patients who have had a previous stroke or transient ischemic attack.
| Status | Completed |
| Enrollment | 4732 |
| Est. completion date | November 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Previous stroke or TIA Exclusion Criteria: - coronary heart disease |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Pfizer Investigational Site | East Gosford | New South Wales |
| Australia | Pfizer Investigational Site | Footscray | Victoria |
| Australia | Pfizer Investigational Site | Heidelberg Heights | Victoria |
| Australia | Pfizer Investigational Site | Parkville | Victoria |
| Australia | Pfizer Investigational Site | Perth | Western Australia |
| Australia | Pfizer Investigational Site | Prahran | Victoria |
| Australia | Pfizer Investigational Site | Randwick, Sydney | New South Wales |
| Austria | Pfizer Investigational Site | Graz | |
| Austria | Pfizer Investigational Site | Innsbruck | |
| Austria | Pfizer Investigational Site | Villach | |
| Austria | Pfizer Investigational Site | Wien | |
| Belgium | Pfizer Investigational Site | Gent | |
| Belgium | Pfizer Investigational Site | Leuven | |
| Belgium | Pfizer Investigational Site | Tielt | |
| Belgium | Pfizer Investigational Site | Waregem | |
| Brazil | Pfizer Investigational Site | Porto Alegre | RS |
| Brazil | Pfizer Investigational Site | Sao Paulo | SP |
| Chile | Pfizer Investigational Site | Vina Del Mar | |
| Czech Republic | Pfizer Investigational Site | Brno | |
| Czech Republic | Pfizer Investigational Site | Ostrava | |
| Czech Republic | Pfizer Investigational Site | Ostrava-Poruba | |
| Czech Republic | Pfizer Investigational Site | Pilsen | |
| Czech Republic | Pfizer Investigational Site | Prague 4 | |
| Czech Republic | Pfizer Investigational Site | Zlin | |
| Denmark | Pfizer Investigational Site | Copenhagen Nv | |
| Denmark | Pfizer Investigational Site | Glostrup | |
| Denmark | Pfizer Investigational Site | Hellerup | |
| Finland | Pfizer Investigational Site | Hus, Helsinki | |
| Finland | Pfizer Investigational Site | Kotka | |
| Finland | Pfizer Investigational Site | Kuopio | |
| Finland | Pfizer Investigational Site | Lahti | |
| Finland | Pfizer Investigational Site | Lappeenranta | |
| Finland | Pfizer Investigational Site | Oulu | |
| France | Pfizer Investigational Site | Besancon | |
| France | Pfizer Investigational Site | Bourg En Bresse | Cedex |
| France | Pfizer Investigational Site | Marseille | |
| France | Pfizer Investigational Site | Nice | |
| France | Pfizer Investigational Site | Paris | |
| France | Pfizer Investigational Site | Paris | Cedex 20 |
| France | Pfizer Investigational Site | Saint Denis | Cedex 1 |
| France | Pfizer Investigational Site | Toulouse | Cedex 3 |
| Germany | Pfizer Investigational Site | Bad Rodach | |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Essen | |
| Germany | Pfizer Investigational Site | Heidelberg | |
| Germany | Pfizer Investigational Site | Leipzig | |
| Germany | Pfizer Investigational Site | Mannheim | |
| Germany | Pfizer Investigational Site | Minden | |
| Germany | Pfizer Investigational Site | Muenchen | |
| Germany | Pfizer Investigational Site | Muenchen | |
| Germany | Pfizer Investigational Site | Muenchen | |
| Germany | Pfizer Investigational Site | Muenster | |
| Germany | Pfizer Investigational Site | Regensburg | |
| Greece | Pfizer Investigational Site | Athens | Melissia |
| Greece | Pfizer Investigational Site | Athens | |
| Greece | Pfizer Investigational Site | Athens | |
| Greece | Pfizer Investigational Site | Thessaloniki | |
| Greece | Pfizer Investigational Site | Thessaloniki | |
| Israel | Pfizer Investigational Site | Haifa | |
| Israel | Pfizer Investigational Site | Holon | |
| Israel | Pfizer Investigational Site | Petach-tikva | |
| Israel | Pfizer Investigational Site | Tel Aviv | |
| Italy | Pfizer Investigational Site | Bari | |
| Italy | Pfizer Investigational Site | Bergamo | |
| Italy | Pfizer Investigational Site | Genova | |
| Italy | Pfizer Investigational Site | Milano | |
| Italy | Pfizer Investigational Site | Monza | |
| Italy | Pfizer Investigational Site | Via Brunamonti 15 | Perugia |
| Mexico | Pfizer Investigational Site | Monterrey | Nuevo Leon |
| Netherlands | Pfizer Investigational Site | Almelo | |
| Netherlands | Pfizer Investigational Site | Delft | |
| Netherlands | Pfizer Investigational Site | Goes | |
| Netherlands | Pfizer Investigational Site | RB Groningen | |
| Netherlands | Pfizer Investigational Site | Rotterdam | GD |
| Netherlands | Pfizer Investigational Site | Tilburg | |
| New Zealand | Pfizer Investigational Site | Auckland | |
| New Zealand | Pfizer Investigational Site | Christchurch | |
| New Zealand | Pfizer Investigational Site | Takapuna | Auckland |
| Poland | Pfizer Investigational Site | Bialystok | |
| Poland | Pfizer Investigational Site | Krakow | |
| Poland | Pfizer Investigational Site | Lublin | |
| Poland | Pfizer Investigational Site | Poznan | |
| Poland | Pfizer Investigational Site | Sosnowiec | |
| Poland | Pfizer Investigational Site | Warszawa | |
| Poland | Pfizer Investigational Site | Warszawa | |
| Poland | Pfizer Investigational Site | Wroclaw | |
| Portugal | Pfizer Investigational Site | Coimbra Codex | |
| Portugal | Pfizer Investigational Site | Lisboa | |
| Portugal | Pfizer Investigational Site | Porto | |
| Slovakia | Pfizer Investigational Site | Bratislava | |
| Slovakia | Pfizer Investigational Site | Bratislava | |
| South Africa | Pfizer Investigational Site | Bloemfontein | |
| South Africa | Pfizer Investigational Site | Cape Town | |
| South Africa | Pfizer Investigational Site | Parow | |
| Spain | Pfizer Investigational Site | Alicante | |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | Burgos | |
| Spain | Pfizer Investigational Site | Girona | |
| Spain | Pfizer Investigational Site | L'Hospitalet (BCN) | Barcelona |
| Spain | Pfizer Investigational Site | Málaga | Malaga |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Palma de Mallorca | |
| Spain | Pfizer Investigational Site | Sevilla | |
| Spain | Pfizer Investigational Site | Sevilla | |
| Spain | Pfizer Investigational Site | Sevilla | |
| Spain | Pfizer Investigational Site | Valencia | |
| Spain | Pfizer Investigational Site | Zaragoza | |
| Sweden | Pfizer Investigational Site | Danderyd | |
| Sweden | Pfizer Investigational Site | Stockholm | |
| Sweden | Pfizer Investigational Site | Stockholm | |
| Sweden | Pfizer Investigational Site | Umea | |
| Sweden | Pfizer Investigational Site | Uppsala | |
| Sweden | Pfizer Investigational Site | Vaestervik | |
| Switzerland | Pfizer Investigational Site | Aarau | |
| Switzerland | Pfizer Investigational Site | Basel | |
| Switzerland | Pfizer Investigational Site | Bern | |
| Switzerland | Pfizer Investigational Site | Lausanne | |
| Switzerland | Pfizer Investigational Site | Zurich | |
| United Kingdom | Pfizer Investigational Site | Aberdeen | |
| United Kingdom | Pfizer Investigational Site | Cardiff | |
| United Kingdom | Pfizer Investigational Site | Dundee | Scotland |
| United Kingdom | Pfizer Investigational Site | Glasgow | |
| United Kingdom | Pfizer Investigational Site | Liverpool | |
| United Kingdom | Pfizer Investigational Site | Newport | South Wales |
| United Kingdom | Pfizer Investigational Site | Nottingham | |
| United Kingdom | Pfizer Investigational Site | Woolwich | |
| Venezuela | Pfizer Investigational Site | Caracas |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
Australia, Austria, Belgium, Brazil, Chile, Czech Republic, Denmark, Finland, France, Germany, Greece, Israel, Italy, Mexico, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom, Venezuela,
Amarenco P, Bogousslavsky J, Callahan A 3rd, Goldstein LB, Hennerici M, Rudolph AE, Sillesen H, Simunovic L, Szarek M, Welch KM, Zivin JA; Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) Investigators. High-dose atorvastatin after — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to occurrence of fatal or non-fatal stroke | |||
| Secondary | Time to occurrence of an acute coronary event, consisting of cardiac death, nonfatal myocardial infarction, resuscitated cardiac arrest or unstable angina. | |||
| Secondary | Time to occurrence of a cerebrovascular event, defined as fatal or nonfatal stroke or TIA. |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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